Trial Outcomes & Findings for Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Dialysis-dependent Chronic Kidney Disease (DD-CKD) (NCT NCT02892149)

Participant milestones
Measure	Vadadustat Participants were randomized to receive Vadadustat at an initial oral dose of 300 milligrams per day (mg/day). Thereafter, Vadadustat was taken once daily on an outpatient basis. Up-and-down titration to 150, 300, 450, and 600 mg (available tablet strength was administered as the appropriate number of 150 mg tablets) was allowed during the study based on hemoglobin (Hb) level measurements to maintain target Hb levels.	Darbepoetin Alfa Participants were randomized to Darbepoetin alfa at an initial dose that was based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics (SmPC) for all other investigational sites (non-US) for adult participants with chronic kidney disease on dialysis. For participants already on Darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.
Overall Study STARTED	1777	1777
Overall Study COMPLETED	1425	1421
Overall Study NOT COMPLETED	352	356

Reasons for withdrawal
Measure	Vadadustat Participants were randomized to receive Vadadustat at an initial oral dose of 300 milligrams per day (mg/day). Thereafter, Vadadustat was taken once daily on an outpatient basis. Up-and-down titration to 150, 300, 450, and 600 mg (available tablet strength was administered as the appropriate number of 150 mg tablets) was allowed during the study based on hemoglobin (Hb) level measurements to maintain target Hb levels.	Darbepoetin Alfa Participants were randomized to Darbepoetin alfa at an initial dose that was based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics (SmPC) for all other investigational sites (non-US) for adult participants with chronic kidney disease on dialysis. For participants already on Darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.
Overall Study Death	262	278
Overall Study Withdrawal by Subject	53	47
Overall Study Lost to Follow-up	37	31

Baseline characteristics by cohort
Measure	Vadadustat n=1777 Participants Participants were randomized to receive Vadadustat at an initial oral dose of 300 milligrams per day (mg/day). Thereafter, Vadadustat was taken once daily on an outpatient basis. Up-and-down titration to 150, 300, 450, and 600 mg (available tablet strength was administered as the appropriate number of 150 mg tablets) was allowed during the study based on hemoglobin (Hb) level measurements to maintain target Hb levels.	Darbepoetin Alfa n=1777 Participants Participants were randomized to Darbepoetin alfa at an initial dose that was based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics (SmPC) for all other investigational sites (non-US) for adult participants with chronic kidney disease on dialysis. For participants already on Darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.	Total n=3554 Participants Total of all reporting groups
Age, Continuous	57.9 Years STANDARD_DEVIATION 13.86 • n=1777 Participants	58.4 Years STANDARD_DEVIATION 13.84 • n=1777 Participants	58.1 Years STANDARD_DEVIATION 13.85 • n=3554 Participants
Sex: Female, Male Female	787 Participants n=1777 Participants	773 Participants n=1777 Participants	1560 Participants n=3554 Participants
Sex: Female, Male Male	990 Participants n=1777 Participants	1004 Participants n=1777 Participants	1994 Participants n=3554 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	19 Participants n=1777 Participants	30 Participants n=1777 Participants	49 Participants n=3554 Participants
Race/Ethnicity, Customized Asian	76 Participants n=1777 Participants	99 Participants n=1777 Participants	175 Participants n=3554 Participants
Race/Ethnicity, Customized Black or African American	432 Participants n=1777 Participants	444 Participants n=1777 Participants	876 Participants n=3554 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	13 Participants n=1777 Participants	6 Participants n=1777 Participants	19 Participants n=3554 Participants
Race/Ethnicity, Customized White	1135 Participants n=1777 Participants	1096 Participants n=1777 Participants	2231 Participants n=3554 Participants
Race/Ethnicity, Customized Not Reported	52 Participants n=1777 Participants	52 Participants n=1777 Participants	104 Participants n=3554 Participants
Race/Ethnicity, Customized Reported as Other	42 Participants n=1777 Participants	45 Participants n=1777 Participants	87 Participants n=3554 Participants
Race/Ethnicity, Customized Multiple	8 Participants n=1777 Participants	5 Participants n=1777 Participants	13 Participants n=3554 Participants
Average hemoglobin	10.249 Grams per deciliter (g/dL) STANDARD_DEVIATION 0.8502 • n=1777 Participants	10.229 Grams per deciliter (g/dL) STANDARD_DEVIATION 0.8245 • n=1777 Participants	10.239 Grams per deciliter (g/dL) STANDARD_DEVIATION 0.8374 • n=3554 Participants
Number of Participants on Different Types of Dialysis Peritoneal Dialysis	137 Participants n=1768 Participants • Participants initiating chronic dialysis was summarized in the Safety Population (INNO2VATE) which included all participants from the INNO2VATE population who received 1 or more doses of study drug.	143 Participants n=1769 Participants • Participants initiating chronic dialysis was summarized in the Safety Population (INNO2VATE) which included all participants from the INNO2VATE population who received 1 or more doses of study drug.	280 Participants n=3537 Participants • Participants initiating chronic dialysis was summarized in the Safety Population (INNO2VATE) which included all participants from the INNO2VATE population who received 1 or more doses of study drug.
Number of Participants on Different Types of Dialysis Hemodialysis	1652 Participants n=1768 Participants • Participants initiating chronic dialysis was summarized in the Safety Population (INNO2VATE) which included all participants from the INNO2VATE population who received 1 or more doses of study drug.	1633 Participants n=1769 Participants • Participants initiating chronic dialysis was summarized in the Safety Population (INNO2VATE) which included all participants from the INNO2VATE population who received 1 or more doses of study drug.	3285 Participants n=3537 Participants • Participants initiating chronic dialysis was summarized in the Safety Population (INNO2VATE) which included all participants from the INNO2VATE population who received 1 or more doses of study drug.
Mean Years Since Chronic Dialysis Initiated	4.004 Years STANDARD_DEVIATION 4.0224 • n=1775 Participants • Participants with missing chronic dialysis initiation date were not included for the analysis.	3.941 Years STANDARD_DEVIATION 4.0144 • n=1777 Participants • Participants with missing chronic dialysis initiation date were not included for the analysis.	3.973 Years STANDARD_DEVIATION 4.0180 • n=3552 Participants • Participants with missing chronic dialysis initiation date were not included for the analysis.
Number of Participants with History of Diabetes	794 Participants n=1777 Participants	820 Participants n=1777 Participants	1614 Participants n=3554 Participants
Number of Participants with NYHA Functional Classification of Heart Failure NYHA Class 0	1243 Participants n=1777 Participants	1221 Participants n=1777 Participants	2464 Participants n=3554 Participants
Number of Participants with NYHA Functional Classification of Heart Failure NYHA Class I	268 Participants n=1777 Participants	307 Participants n=1777 Participants	575 Participants n=3554 Participants
Number of Participants with NYHA Functional Classification of Heart Failure NYHA Class II	202 Participants n=1777 Participants	192 Participants n=1777 Participants	394 Participants n=3554 Participants
Number of Participants with NYHA Functional Classification of Heart Failure NYHA Class III	59 Participants n=1777 Participants	53 Participants n=1777 Participants	112 Participants n=3554 Participants
Number of Participants with NYHA Functional Classification of Heart Failure NYHA Class IV	0 Participants n=1777 Participants	0 Participants n=1777 Participants	0 Participants n=3554 Participants
Number of Participants with NYHA Functional Classification of Heart Failure NYHA Class Missing	5 Participants n=1777 Participants	4 Participants n=1777 Participants	9 Participants n=3554 Participants
Number of Participants with Any History of Heart Failure Yes	361 Participants n=1777 Participants	368 Participants n=1777 Participants	729 Participants n=3554 Participants
Number of Participants with Any History of Heart Failure No	990 Participants n=1777 Participants	985 Participants n=1777 Participants	1975 Participants n=3554 Participants
Number of Participants with Any History of Heart Failure Missing	426 Participants n=1777 Participants	424 Participants n=1777 Participants	850 Participants n=3554 Participants

Outcome measures
Measure	Vadadustat n=1777 Participants Participants were randomized to receive Vadadustat at an initial oral dose of 300 milligrams per day (mg/day). Thereafter, Vadadustat was taken once daily on an outpatient basis. Up-and-down titration to 150, 300, 450, and 600 mg (available tablet strength was administered as the appropriate number of 150 mg tablets) was allowed during the study based on hemoglobin (Hb) level measurements to maintain target Hb levels.	Darbepoetin Alfa n=1777 Participants Participants were randomized to Darbepoetin alfa at an initial dose that was based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics (SmPC) for all other investigational sites (non-US) for adult participants with chronic kidney disease on dialysis. For participants already on Darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.
Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36)	0.19 Grams per deciliter (g/dL) Standard Error 0.032	0.36 Grams per deciliter (g/dL) Standard Error 0.032

Outcome measures
Measure	Vadadustat n=333 Participants Participants were randomized to receive Vadadustat at an initial oral dose of 300 milligrams per day (mg/day). Thereafter, Vadadustat was taken once daily on an outpatient basis. Up-and-down titration to 150, 300, 450, and 600 mg (available tablet strength was administered as the appropriate number of 150 mg tablets) was allowed during the study based on hemoglobin (Hb) level measurements to maintain target Hb levels.	Darbepoetin Alfa n=353 Participants Participants were randomized to Darbepoetin alfa at an initial dose that was based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics (SmPC) for all other investigational sites (non-US) for adult participants with chronic kidney disease on dialysis. For participants already on Darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.
Median Time to First Major Adverse Cardiovascular Event (MACE)	48.86 Weeks Interval 26.43 to 79.71	48.00 Weeks Interval 22.43 to 75.57

Outcome measures
Measure	Vadadustat n=1777 Participants Participants were randomized to receive Vadadustat at an initial oral dose of 300 milligrams per day (mg/day). Thereafter, Vadadustat was taken once daily on an outpatient basis. Up-and-down titration to 150, 300, 450, and 600 mg (available tablet strength was administered as the appropriate number of 150 mg tablets) was allowed during the study based on hemoglobin (Hb) level measurements to maintain target Hb levels.	Darbepoetin Alfa n=1777 Participants Participants were randomized to Darbepoetin alfa at an initial dose that was based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics (SmPC) for all other investigational sites (non-US) for adult participants with chronic kidney disease on dialysis. For participants already on Darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.
Change From Baseline in Hb to the Average Over the Secondary Efficacy Period (Weeks 40 to 52)	0.23 g/dL Standard Error 0.035	0.41 g/dL Standard Error 0.033

Outcome measures
Measure	Vadadustat n=391 Participants Participants were randomized to receive Vadadustat at an initial oral dose of 300 milligrams per day (mg/day). Thereafter, Vadadustat was taken once daily on an outpatient basis. Up-and-down titration to 150, 300, 450, and 600 mg (available tablet strength was administered as the appropriate number of 150 mg tablets) was allowed during the study based on hemoglobin (Hb) level measurements to maintain target Hb levels.	Darbepoetin Alfa n=418 Participants Participants were randomized to Darbepoetin alfa at an initial dose that was based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics (SmPC) for all other investigational sites (non-US) for adult participants with chronic kidney disease on dialysis. For participants already on Darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.
Median Time to First MACE Plus Hospitalization for Heart Failure or Thromboembolic Event Excluding Vascular Access Thrombosis	43.29 Weeks Interval 21.86 to 73.14	45.21 Weeks Interval 22.29 to 73.86

Outcome measures
Measure	Vadadustat n=209 Participants Participants were randomized to receive Vadadustat at an initial oral dose of 300 milligrams per day (mg/day). Thereafter, Vadadustat was taken once daily on an outpatient basis. Up-and-down titration to 150, 300, 450, and 600 mg (available tablet strength was administered as the appropriate number of 150 mg tablets) was allowed during the study based on hemoglobin (Hb) level measurements to maintain target Hb levels.	Darbepoetin Alfa n=228 Participants Participants were randomized to Darbepoetin alfa at an initial dose that was based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics (SmPC) for all other investigational sites (non-US) for adult participants with chronic kidney disease on dialysis. For participants already on Darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.
Median Time to First Cardiovascular MACE	44.57 Weeks Interval 23.29 to 81.86	43.57 Weeks Interval 20.71 to 73.93

Outcome measures
Measure	Vadadustat n=141 Participants Participants were randomized to receive Vadadustat at an initial oral dose of 300 milligrams per day (mg/day). Thereafter, Vadadustat was taken once daily on an outpatient basis. Up-and-down titration to 150, 300, 450, and 600 mg (available tablet strength was administered as the appropriate number of 150 mg tablets) was allowed during the study based on hemoglobin (Hb) level measurements to maintain target Hb levels.	Darbepoetin Alfa n=150 Participants Participants were randomized to Darbepoetin alfa at an initial dose that was based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics (SmPC) for all other investigational sites (non-US) for adult participants with chronic kidney disease on dialysis. For participants already on Darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.
Median Time to First Cardiovascular Death	46.14 Weeks Interval 29.43 to 79.0	47.64 Weeks Interval 24.57 to 74.14

Outcome measures
Measure	Vadadustat n=276 Participants Participants were randomized to receive Vadadustat at an initial oral dose of 300 milligrams per day (mg/day). Thereafter, Vadadustat was taken once daily on an outpatient basis. Up-and-down titration to 150, 300, 450, and 600 mg (available tablet strength was administered as the appropriate number of 150 mg tablets) was allowed during the study based on hemoglobin (Hb) level measurements to maintain target Hb levels.	Darbepoetin Alfa n=290 Participants Participants were randomized to Darbepoetin alfa at an initial dose that was based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics (SmPC) for all other investigational sites (non-US) for adult participants with chronic kidney disease on dialysis. For participants already on Darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.
Median Time to First All-cause Mortality	50.79 Weeks Interval 30.29 to 80.5	50.43 Weeks Interval 26.14 to 78.86

Cardiac disorders

Cardiac tamponade

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Pneumonia

7.9%

140/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

6.7%

119/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Metabolism and nutrition disorders

Fluid overload

5.5%

98/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

5.5%

98/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Sepsis

4.3%

76/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

5.0%

88/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Acute myocardial infarction

4.6%

81/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

4.4%

78/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Metabolism and nutrition disorders

Hyperkalaemia

3.1%

55/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

4.3%

76/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Cardiac arrest

2.8%

49/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

3.4%

60/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Cardiac failure congestive

2.5%

45/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

2.8%

50/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Arteriovenous fistula thrombosis

3.2%

56/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

2.1%

38/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Acute respiratory failure

2.5%

44/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

2.8%

50/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Septic shock

2.5%

44/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

2.5%

45/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Atrial fibrillation

2.5%

44/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

2.1%

37/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Cellulitis

2.4%

43/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

2.1%

38/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Blood and lymphatic system disorders

Anaemia

2.0%

35/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

2.1%

37/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Osteomyelitis

1.8%

31/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

2.2%

39/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Respiratory failure

1.5%

27/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

2.4%

42/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Gastrointestinal haemorrhage

1.9%

34/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

1.6%

29/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Coronary artery disease

1.6%

28/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

1.8%

32/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Pulmonary oedema

1.5%

26/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

1.9%

33/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Hypotension

1.6%

29/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

1.7%

30/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Non-cardiac chest pain

1.9%

34/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

1.2%

22/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Cardio-respiratory arrest

1.6%

28/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

1.5%

26/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Peritonitis

1.2%

21/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

1.8%

32/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Pleural effusion

1.5%

26/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

1.5%

26/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Device related infection

1.4%

25/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

1.3%

23/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Gangrene

1.4%

24/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

1.3%

23/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Urinary tract infection

0.85%

15/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

1.8%

32/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Metabolic encephalopathy

1.1%

20/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

1.4%

25/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Cardiac failure acute

1.0%

18/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

1.5%

26/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Hypertensive urgency

1.1%

19/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

1.4%

25/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Arteriovenous graft thrombosis

1.2%

22/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

1.1%

20/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Hypertension

1.1%

20/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

1.2%

22/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Blood and lymphatic system disorders

Blood loss anaemia

0.90%

16/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

1.4%

24/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Metabolism and nutrition disorders

Hypoglycaemia

1.2%

22/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

1.0%

18/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Syncope

1.2%

22/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

1.0%

18/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Death

1.4%

24/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.79%

14/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Acute left ventricular failure

0.74%

13/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

1.3%

23/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Influenza

1.1%

20/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.85%

15/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Fall

0.96%

17/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

1.0%

18/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Staphylococcal sepsis

0.90%

16/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

1.0%

18/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Arteriovenous fistula site complication

0.90%

16/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

1.0%

18/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Psychiatric disorders

Mental status changes

0.62%

11/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

1.3%

23/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Hypertensive emergency

0.90%

16/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

1.0%

18/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Staphylococcal bacteraemia

0.96%

17/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.85%

15/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Acute pulmonary oedema

1.1%

19/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.73%

13/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Bronchitis

0.68%

12/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

1.1%

19/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Cerebrovascular accident

0.79%

14/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.90%

16/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Chest pain

0.79%

14/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.85%

15/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Chronic obstructive pulmonary disease

0.90%

16/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.68%

12/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Dyspnoea

1.1%

19/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.51%

9/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Encephalopathy

0.74%

13/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.68%

12/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Ischaemic stroke

0.74%

13/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.68%

12/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Multiple organ dysfunction syndrome

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.40%

7/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Hypertensive crisis

0.68%

12/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.73%

13/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Cardiogenic shock

0.57%

10/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.79%

14/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Renal and urinary disorders

End stage renal disease

0.85%

15/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.51%

9/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Arteriovenous fistula site haemorrhage

0.62%

11/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.68%

12/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Deep vein thrombosis

0.74%

13/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.57%

10/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Peripheral vascular disorder

0.74%

13/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.57%

10/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Myocardial infarction

0.57%

10/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.68%

12/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Arteriovenous graft site infection

0.45%

8/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.79%

14/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Gastroenteritis

0.45%

8/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.79%

14/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Femur fracture

0.85%

15/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.40%

7/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Angina unstable

0.45%

8/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.73%

13/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Cardiac failure

0.51%

9/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.62%

11/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Abdominal pain

0.45%

8/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.68%

12/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Bacteraemia

0.51%

9/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.62%

11/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Endocarditis

0.28%

5/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.85%

15/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Vascular access malfunction

0.57%

10/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.57%

10/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Vascular access site thrombosis

0.40%

7/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.73%

13/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Seizure

0.34%

6/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.79%

14/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Transient ischaemic attack

0.85%

15/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.28%

5/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Pulmonary hypertension

0.57%

10/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.57%

10/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Angina pectoris

0.45%

8/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.62%

11/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Arteriovenous fistula site infection

0.68%

12/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.40%

7/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Clostridium difficile colitis

0.40%

7/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.68%

12/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Diverticulitis

0.51%

9/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.57%

10/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Pneumonia bacterial

0.40%

7/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.68%

12/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Skin and subcutaneous tissue disorders

Diabetic foot

0.40%

7/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.68%

12/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Pancreatitis acute

0.57%

10/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.45%

8/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Postoperative wound infection

0.28%

5/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.73%

13/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Colitis

0.45%

8/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.51%

9/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Gastritis

0.51%

9/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.45%

8/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Upper gastrointestinal haemorrhage

0.28%

5/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.68%

12/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Hip fracture

0.34%

6/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.62%

11/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Ventricular tachycardia

0.51%

9/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.40%

7/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Small intestinal obstruction

0.40%

7/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.51%

9/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Hepatobiliary disorders

Cholelithiasis

0.40%

7/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.51%

9/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Atrial flutter

0.34%

6/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.51%

9/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Bradycardia

0.23%

4/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.62%

11/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Hepatobiliary disorders

Cholecystitis acute

0.34%

6/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.51%

9/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Investigations

Hepatic enzyme increased

0.40%

7/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.45%

8/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Renal and urinary disorders

Azotaemia

0.57%

10/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.28%

5/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Peripheral arterial occlusive disease

0.40%

7/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.45%

8/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Pericardial effusion

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.68%

12/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Device related sepsis

0.40%

7/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.40%

7/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Back pain

0.28%

5/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.51%

9/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Pulmonary embolism

0.28%

5/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.51%

9/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Extremity necrosis

0.45%

8/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.34%

6/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Cardiopulmonary failure

0.45%

8/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.28%

5/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Diarrhoea

0.34%

6/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.40%

7/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Abscess limb

0.40%

7/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.34%

6/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Subdural haematoma

0.34%

6/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.40%

7/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Investigations

Alanine aminotransferase increased

0.40%

7/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.34%

6/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Peripheral ischaemia

0.40%

7/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.34%

6/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Ascites

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.51%

9/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Lower gastrointestinal haemorrhage

0.28%

5/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.40%

7/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Asthenia

0.34%

6/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.34%

6/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Sudden death

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.51%

9/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Investigations

Aspartate aminotransferase increased

0.34%

6/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.34%

6/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Metabolism and nutrition disorders

Hyperglycaemia

0.34%

6/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.34%

6/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Metabolism and nutrition disorders

Hyponatraemia

0.34%

6/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.34%

6/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Musculoskeletal chest pain

0.28%

5/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.40%

7/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Left ventricular failure

0.23%

4/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.40%

7/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Impaired gastric emptying

0.34%

6/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.28%

5/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Intestinal ischaemia

0.45%

8/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Pancreatitis

0.28%

5/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.34%

6/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Pyrexia

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.45%

8/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Diabetic foot infection

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.45%

8/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Investigations

Transaminases increased

0.45%

8/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Metabolism and nutrition disorders

Hypervolaemia

0.28%

5/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.34%

6/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Pain in extremity

0.40%

7/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Skin and subcutaneous tissue disorders

Skin ulcer

0.23%

4/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.40%

7/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Haematoma

0.51%

9/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Shock haemorrhagic

0.45%

8/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Acute coronary syndrome

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.45%

8/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Mitral valve incompetence

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.45%

8/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Colitis ischaemic

0.28%

5/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.28%

5/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Hepatobiliary disorders

Cholecystitis

0.40%

7/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Catheter site infection

0.23%

4/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.34%

6/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Localised infection

0.28%

5/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.28%

5/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Wound infection

0.28%

5/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.28%

5/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Ankle fracture

0.34%

6/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Post procedural haemorrhage

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.40%

7/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Metabolism and nutrition disorders

Diabetic ketoacidosis

0.28%

5/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.28%

5/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Haemorrhagic stroke

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.40%

7/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Product Issues

Device dislocation

0.34%

6/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Aortic stenosis

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.40%

7/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Jugular vein thrombosis

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.40%

7/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Shock

0.28%

5/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.28%

5/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Intestinal obstruction

0.40%

7/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Appendicitis

0.23%

4/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.28%

5/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Staphylococcal infection

0.23%

4/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.28%

5/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Arteriovenous graft site haemorrhage

0.23%

4/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.28%

5/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Femoral neck fracture

0.34%

6/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Wound dehiscence

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.40%

7/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Metabolism and nutrition disorders

Hypocalcaemia

0.34%

6/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Osteoarthritis

0.28%

5/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Hepatic encephalopathy

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.34%

6/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Hypoxic-ischaemic encephalopathy

0.28%

5/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Pneumonia aspiration

0.28%

5/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Blood and lymphatic system disorders

Nephrogenic anaemia

0.34%

6/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Myocardial ischaemia

0.23%

4/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Constipation

0.34%

6/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Duodenal ulcer

0.34%

6/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Catheter site thrombosis

0.28%

5/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Fibula fracture

0.23%

4/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Tibia fracture

0.23%

4/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Vascular pseudoaneurysm

0.23%

4/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Dizziness

0.23%

4/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Skin and subcutaneous tissue disorders

Decubitus ulcer

0.23%

4/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Pulseless electrical activity

0.23%

4/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Ventricular fibrillation

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Inguinal hernia

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Nausea

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.28%

5/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Impaired healing

0.34%

6/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Systemic inflammatory response syndrome

0.23%

4/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Hepatobiliary disorders

Bile duct stone

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.34%

6/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Cytomegalovirus infection

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Osteomyelitis acute

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.34%

6/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Peritonitis bacterial

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Urosepsis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.34%

6/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Spinal compression fracture

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.34%

6/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Vascular pseudoaneurysm ruptured

0.23%

4/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Metabolism and nutrition disorders

Hypokalaemia

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Cerebral haemorrhage

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Cerebral infarction

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Presyncope

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.28%

5/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Renal and urinary disorders

Acute kidney injury

0.23%

4/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Acute respiratory distress syndrome

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.28%

5/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Dry gangrene

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Peripheral artery thrombosis

0.23%

4/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Blood and lymphatic system disorders

Pancytopenia

0.23%

4/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Arrhythmia

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.28%

5/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Atrioventricular block complete

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Chronic left ventricular failure

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Supraventricular tachycardia

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Tachycardia

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.28%

5/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Chronic gastritis

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Gastritis erosive

0.23%

4/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Ileus

0.23%

4/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Melaena

0.23%

4/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Rectal haemorrhage

0.23%

4/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Vomiting

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Arthritis bacterial

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Fungal peritonitis

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Arteriovenous fistula aneurysm

0.23%

4/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Contusion

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Graft thrombosis

0.28%

5/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Humerus fracture

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Lower limb fracture

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Perirenal haematoma

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Pubis fracture

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Toxicity to various agents

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Investigations

Liver function test increased

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Carotid artery stenosis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.28%

5/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Haemorrhage intracranial

0.28%

5/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Hypertensive encephalopathy

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Product Issues

Device malfunction

0.23%

4/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Renal and urinary disorders

Haematuria

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Asthma

0.23%

4/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Cardiac failure chronic

0.28%

5/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Coronary artery stenosis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Ischaemic cardiomyopathy

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Sinus node dysfunction

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Endocrine disorders

Hyperparathyroidism

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Endocrine disorders

Hyperparathyroidism secondary

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Abdominal pain upper

0.28%

5/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Diabetic gastroparesis

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Duodenal ulcer haemorrhage

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Gastrooesophageal reflux disease

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Haemorrhoidal haemorrhage

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Catheter site haemorrhage

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Hepatobiliary disorders

Hepatic cirrhosis

0.23%

4/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Immune system disorders

Kidney transplant rejection

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Gastroenteritis viral

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Infected skin ulcer

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Pyelonephritis

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Streptococcal bacteraemia

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Subcutaneous abscess

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Upper respiratory tract infection

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Arteriovenous fistula occlusion

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Head injury

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Procedural pain

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Rib fracture

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Vascular graft complication

0.23%

4/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Muscular weakness

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Musculoskeletal pain

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Brain injury

0.23%

4/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Uraemic encephalopathy

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Renal and urinary disorders

Chronic kidney disease

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Epistaxis

0.23%

4/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Hypoxia

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Pneumothorax

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Pulmonary congestion

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Respiratory arrest

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.28%

5/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Respiratory distress

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Arteriosclerosis

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Hypovolaemic shock

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Orthostatic hypotension

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Peripheral artery occlusion

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Steal syndrome

0.23%

4/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Coronary artery occlusion

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Pericarditis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Tricuspid valve incompetence

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Eye disorders

Cataract

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Diverticular perforation

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Faecaloma

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Haematochezia

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Haemorrhoids

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Peptic ulcer haemorrhage

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Peritoneal haemorrhage

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Generalised oedema

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Sudden cardiac death

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Hepatobiliary disorders

Ischaemic hepatitis

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Bronchitis viral

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Enterococcal bacteraemia

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Gas gangrene

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Intervertebral discitis

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Large intestine infection

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Lower respiratory tract infection

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Pneumonia viral

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Pseudomonal bacteraemia

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Vascular access site infection

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Viral infection

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Arteriovenous graft site stenosis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Delayed graft function

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Eschar

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Pelvic fracture

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Road traffic accident

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Investigations

Troponin increased

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Metabolism and nutrition disorders

Lactic acidosis

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Lumbar spinal stenosis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Myositis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Clear cell renal cell carcinoma

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Prostate cancer

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Renal cell carcinoma

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Status epilepticus

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Subarachnoid haemorrhage

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.23%

4/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Psychiatric disorders

Anxiety

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Psychiatric disorders

Delirium

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Chronic respiratory failure

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Skin and subcutaneous tissue disorders

Angioedema

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Skin and subcutaneous tissue disorders

Diabetic ulcer

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Skin and subcutaneous tissue disorders

Skin necrosis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Surgical and medical procedures

Hospitalisation

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Malignant hypertension

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Blood and lymphatic system disorders

Splenic infarction

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Congestive cardiomyopathy

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Palpitations

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Sinus tachycardia

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Ear and labyrinth disorders

Vertigo

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Endocrine disorders

Hyperthyroidism

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Abdominal wall haematoma

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Enteritis

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Gastric ulcer

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Gastric ulcer haemorrhage

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Gastritis haemorrhagic

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Hiatus hernia

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Intestinal haemorrhage

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Pancreatitis chronic

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Peptic ulcer

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Physical deconditioning

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Treatment noncompliance

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Hepatobiliary disorders

Liver injury

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Abdominal abscess

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Acute hepatitis B

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Bacterial sepsis

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Candida infection

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Cholecystitis infective

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Clostridium difficile infection

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Diabetic gangrene

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Endocarditis bacterial

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Endocarditis staphylococcal

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Escherichia bacteraemia

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Infection

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Otitis externa

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Pneumonia influenzal

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Pyelonephritis acute

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Sinusitis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Soft tissue infection

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Staphylococcal abscess

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Tooth abscess

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Tracheobronchitis

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Foot fracture

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Joint dislocation

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Joint injury

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Peritoneal dialysis complication

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Post procedural haematoma

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Postoperative hypotension

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Procedural hypotension

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Shunt thrombosis

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Vascular access site haemorrhage

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Vascular access site pseudoaneurysm

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Wound necrosis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Metabolism and nutrition disorders

Calciphylaxis

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Metabolism and nutrition disorders

Malnutrition

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Flank pain

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Adenocarcinoma

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Adenocarcinoma of colon

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Breast cancer

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colon cancer

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastatic renal cell carcinoma

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Altered state of consciousness

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Brain hypoxia

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Brain oedema

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Cerebellar infarction

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Cerebral haematoma

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Embolic stroke

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Generalised tonic-clonic seizure

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Hypoglycaemic encephalopathy

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Lacunar infarction

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.17%

3/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Psychiatric disorders

Confusional state

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Psychiatric disorders

Depression

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Renal and urinary disorders

Nephrolithiasis

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Renal and urinary disorders

Renal cyst

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Reproductive system and breast disorders

Dysfunctional uterine bleeding

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Reproductive system and breast disorders

Menorrhagia

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Aspiration

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Atelectasis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Respiratory acidosis

0.17%

3/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Brachiocephalic vein occlusion

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Haemorrhage

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Superior vena cava syndrome

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Venous stenosis

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Blood and lymphatic system disorders

Leukocytosis

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Blood and lymphatic system disorders

Thrombocytopenia

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Aortic valve incompetence

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Arteriosclerosis coronary artery

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Atrial tachycardia

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Atrial thrombosis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Atrioventricular block

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Atrioventricular block first degree

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Atrioventricular block second degree

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Cardiomyopathy

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Coronary artery thrombosis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Diastolic dysfunction

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Hypertensive heart disease

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Nodal arrhythmia

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Ventricular arrhythmia

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Congenital, familial and genetic disorders

Gastrointestinal arteriovenous malformation

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Ear and labyrinth disorders

Vertigo positional

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Endocrine disorders

Hyperparathyroidism tertiary

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Abdominal distension

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Abdominal hernia obstructive

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Diverticulum

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Diverticulum intestinal haemorrhagic

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Duodenitis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Dysphagia

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Erosive oesophagitis

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Gastric antral vascular ectasia

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Gastric ulcer perforation

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Gastrointestinal necrosis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Haematemesis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Haemorrhagic erosive gastritis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Ileus paralytic

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Incarcerated umbilical hernia

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Intra-abdominal haematoma

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Obstructive pancreatitis

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Oesophageal ulcer

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Retroperitoneal haemorrhage

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Umbilical hernia

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Catheter site pain

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Complication associated with device

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Oedema peripheral

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Pain

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Peripheral swelling

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Surgical failure

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Hepatobiliary disorders

Biliary colic

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Hepatobiliary disorders

Cholestasis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Hepatobiliary disorders

Hepatic failure

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Immune system disorders

Anaphylactic reaction

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Immune system disorders

Anaphylactic shock

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Adenovirus infection

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Arthritis infective

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Atypical pneumonia

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Breast abscess

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Catheter site abscess

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Cellulitis staphylococcal

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Chronic hepatitis B

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Cystitis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Empyema

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Enterococcal infection

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Enterococcal sepsis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Escherichia pyelonephritis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Escherichia sepsis

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Gastroenteritis bacterial

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Graft infection

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Herpes zoster

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Infectious pleural effusion

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Klebsiella infection

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Meningitis

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Orchitis

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Perineal abscess

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Pneumonia klebsiella

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Pneumonia necrotising

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Pneumonia serratia

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Post procedural cellulitis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Pseudomonas infection

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Pyelonephritis chronic

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Renal graft infection

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Respiratory tract infection

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Scrotal abscess

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Staphylococcal osteomyelitis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Streptococcal sepsis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Tooth infection

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Vascular device infection

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Viral upper respiratory tract infection

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Vulval abscess

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Wound infection staphylococcal

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Acetabulum fracture

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Anaemia postoperative

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Arteriovenous fistula site haematoma

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Clavicle fracture

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Facial bones fracture

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Ligament sprain

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Multiple injuries

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Overdose

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Patella fracture

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Postoperative respiratory failure

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Renal lymphocele

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Skin laceration

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Ulna fracture

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Vascular access site complication

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Vascular graft thrombosis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Investigations

Anticoagulation drug level above therapeutic

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Investigations

False positive investigation result

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Metabolism and nutrition disorders

Dehydration

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Metabolism and nutrition disorders

Diabetes mellitus inadequate control

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Metabolism and nutrition disorders

Failure to thrive

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Metabolism and nutrition disorders

Metabolic acidosis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Metabolism and nutrition disorders

Obesity

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Arthralgia

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Cervical spinal stenosis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Myopathy

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Neck pain

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Neuropathic arthropathy

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Osteitis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Osteonecrosis

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Spinal osteoarthritis

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Spinal stenosis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Vertebral foraminal stenosis

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bladder cancer

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colon adenoma

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Gastric cancer

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Hepatocellular carcinoma

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Invasive ductal breast carcinoma

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung adenocarcinoma

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Myelodysplastic syndrome

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Pancreatic carcinoma

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Pancreatic carcinoma metastatic

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Papillary thyroid cancer

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Parathyroid tumour benign

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Prostate cancer metastatic

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Rectal neoplasm

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Renal cancer

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Squamous cell carcinoma

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Coma

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Diabetic neuropathy

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Haemorrhagic cerebral infarction

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Hypoglycaemic seizure

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Myoclonus

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Neurotoxicity

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Toxic encephalopathy

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Product Issues

Device occlusion

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Product Issues

Thrombosis in device

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Renal and urinary disorders

Hydronephrosis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Renal and urinary disorders

Renal failure

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Renal and urinary disorders

Tubulointerstitial nephritis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Renal and urinary disorders

Urethral stenosis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Reproductive system and breast disorders

Balanoposthitis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Reproductive system and breast disorders

Benign prostatic hyperplasia

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Reproductive system and breast disorders

Menometrorrhagia

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Reproductive system and breast disorders

Penile vascular disorder

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Reproductive system and breast disorders

Vaginal haemorrhage

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Haemoptysis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Haemothorax

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Hypercapnia

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Lung disorder

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Pleurisy

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Pulmonary arterial hypertension

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Skin and subcutaneous tissue disorders

Ischaemic skin ulcer

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Surgical and medical procedures

Therapy cessation

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Brachiocephalic vein thrombosis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Peripheral artery stenosis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Subclavian vein thrombosis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Superior vena cava occlusion

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Thrombophlebitis superficial

0.11%

2/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Thrombosis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Venous thrombosis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.11%

2/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Blood and lymphatic system disorders

Autoimmune haemolytic anaemia

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Blood and lymphatic system disorders

Bicytopenia

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Blood and lymphatic system disorders

Bone marrow failure

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Blood and lymphatic system disorders

Coagulopathy

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Blood and lymphatic system disorders

Disseminated intravascular coagulation

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Blood and lymphatic system disorders

Haemolytic uraemic syndrome

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Blood and lymphatic system disorders

Haemorrhagic diathesis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Blood and lymphatic system disorders

Haemorrhagic disorder

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Blood and lymphatic system disorders

Iron deficiency anaemia

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Blood and lymphatic system disorders

Leukopenia

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Blood and lymphatic system disorders

Lymphadenopathy

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Blood and lymphatic system disorders

Macrocytosis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Blood and lymphatic system disorders

Normocytic anaemia

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Blood and lymphatic system disorders

Splenic artery perforation

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Blood and lymphatic system disorders

Splenomegaly

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Blood and lymphatic system disorders

Thrombotic thrombocytopenic purpura

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Aortic valve disease

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Aortic valve stenosis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Bradyarrhythmia

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Cardiac disorder

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Cardiac valve disease

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Cardiomegaly

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Cardiovascular disorder

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Cor pulmonale

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Coronary artery insufficiency

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Dressler's syndrome

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Intracardiac mass

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Intracardiac thrombus

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Left ventricular hypertrophy

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Mitral valve calcification

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Mitral valve disease

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Myocarditis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Pericardial haemorrhage

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Pericarditis uraemic

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Right ventricular failure

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Silent myocardial infarction

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Sinus bradycardia

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Stress cardiomyopathy

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Cardiac disorders

Ventricular hypokinesia

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Congenital, familial and genetic disorders

Haemorrhagic arteriovenous malformation

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Endocrine disorders

Adrenal mass

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Endocrine disorders

Hypothyroidism

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Endocrine disorders

Thyroid mass

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Eye disorders

Blindness

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Eye disorders

Blindness unilateral

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Eye disorders

Diabetic retinopathy

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Eye disorders

Diplopia

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Eye disorders

Mydriasis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Eye disorders

Optic ischaemic neuropathy

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Eye disorders

Retinal artery thrombosis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Eye disorders

Uveitis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Eye disorders

Vitreous haemorrhage

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Abdominal adhesions

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Abdominal discomfort

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Abdominal hernia

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Abdominal incarcerated hernia

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Abdominal wall oedema

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Anal fissure

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Dental caries

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Diabetic gastropathy

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Dieulafoy's vascular malformation

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Diverticulum intestinal

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Duodenal polyp

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Dyspepsia

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Enterocolitis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Epigastric discomfort

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Gastrointestinal angiectasia

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Gastrointestinal angiodysplasia

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Gastrointestinal inflammation

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Gastrointestinal vascular malformation haemorrhagic

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Gastrointestinal wall thickening

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Hypoaesthesia oral

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Ileal perforation

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Ileal ulcer

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Incarcerated inguinal hernia

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Inflammatory bowel disease

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Inguinal hernia, obstructive

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Intestinal infarction

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Intestinal perforation

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Intestinal pseudo-obstruction

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Intra-abdominal fluid collection

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Intussusception

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Irritable bowel syndrome

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Large intestinal obstruction

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Large intestinal ulcer

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Large intestinal ulcer haemorrhage

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Large intestine perforation

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Mesenteric vein thrombosis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Oesophageal motility disorder

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Oesophagitis ulcerative

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Pancreatic duct dilatation

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Pancreatitis necrotising

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Pneumoperitoneum

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Portal hypertensive gastropathy

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Rectal polyp

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Rectal ulcer

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Rectal ulcer haemorrhage

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Retroperitoneal haematoma

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Small intestinal haemorrhage

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Subileus

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Thrombosis mesenteric vessel

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Uraemic gastropathy

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Gastrointestinal disorders

Varices oesophageal

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Cardiac death

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Catheter site inflammation

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Catheter site related reaction

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Chest discomfort

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Drug withdrawal syndrome

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Fatigue

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Gait disturbance

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Hernia pain

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Hypothermia

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Incarcerated hernia

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Necrosis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Oedema

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Soft tissue inflammation

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Strangulated hernia

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Swelling

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Ulcer

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

General disorders

Vascular stent occlusion

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Hepatobiliary disorders

Acute hepatic failure

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Hepatobiliary disorders

Bile duct stenosis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Hepatobiliary disorders

Cholangitis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Hepatobiliary disorders

Cholecystitis chronic

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Hepatobiliary disorders

Cholelithiasis obstructive

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Hepatobiliary disorders

Chronic hepatic failure

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Hepatobiliary disorders

Hepatic haematoma

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Hepatobiliary disorders

Hepatic mass

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Hepatobiliary disorders

Hepatitis acute

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Immune system disorders

Anti-neutrophil cytoplasmic antibody positive vasculitis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Immune system disorders

Contrast media allergy

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Immune system disorders

Contrast media reaction

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Immune system disorders

Food allergy

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Immune system disorders

Hypersensitivity

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Immune system disorders

Renal transplant failure

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Immune system disorders

Transplant rejection

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Abdominal sepsis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Abscess

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Abscess jaw

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Abscess neck

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Achromobacter infection

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Acute sinusitis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Anal abscess

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Appendicitis perforated

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Atypical mycobacterial pneumonia

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Bacterial diarrhoea

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Bacterial infection

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Bacteriuria

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Bone abscess

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Bone tuberculosis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Bronchitis bacterial

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Bullous impetigo

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Candida sepsis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Carbuncle

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Cellulitis gangrenous

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Cerebral septic infarct

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Colonic abscess

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Conjunctivitis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Corona virus infection

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Cystitis klebsiella

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Diverticulitis intestinal haemorrhagic

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Ear infection

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Emphysematous cholecystitis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Encephalitis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Enterobacter sepsis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Epididymitis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Erysipelas

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Extradural abscess

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Fournier's gangrene

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Furuncle

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Gastrointestinal bacterial overgrowth

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Gastrointestinal viral infection

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Genital herpes

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Giardiasis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Groin infection

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Implant site cellulitis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Incision site abscess

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Infected seroma

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Klebsiella sepsis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Labyrinthitis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Mastoiditis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Mediastinitis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Meningitis viral

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Mycobacterium fortuitum infection

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Necrotising fasciitis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Oesophageal candidiasis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Oral candidiasis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Osteomyelitis bacterial

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Osteomyelitis chronic

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Otitis media

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Paraspinal abscess

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Pelvic abscess

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Perinephric abscess

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Periorbital cellulitis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Perirectal abscess

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Peritoneal abscess

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Peritonsillar abscess

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Pharyngeal abscess

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Pharyngitis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Pharyngitis streptococcal

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Pneumonia cytomegaloviral

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Pneumonia haemophilus

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Pneumonia moraxella

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Pneumonia mycoplasmal

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Pneumonia pneumococcal

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Pneumonia pseudomonal

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Pneumonia staphylococcal

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Post procedural sepsis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Pseudomembranous colitis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Pseudomonas peritonitis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Pulmonary sepsis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Pulmonary tuberculosis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Pyuria

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Renal abscess

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Respiratory syncytial virus bronchitis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Retroperitoneal abscess

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Rhinovirus infection

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Rhodococcus infection

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Septic embolus

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Septic encephalopathy

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Sialoadenitis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Splenic infection

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Staphylococcal skin infection

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Systemic infection

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Testicular abscess

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Tracheitis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Tracheobronchitis viral

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Transplant abscess

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Urinary tract infection bacterial

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Vessel puncture site infection

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Viral diarrhoea

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Infections and infestations

Viral sepsis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Abdominal wound dehiscence

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Accidental overdose

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Anastomotic leak

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Anastomotic ulcer

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Anastomotic ulcer haemorrhage

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Arterial injury

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Arteriovenous graft site haematoma

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Cardiac valve replacement complication

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Cervical vertebral fracture

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Comminuted fracture

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Complications of transplanted kidney

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Compression fracture

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Dialysis disequilibrium syndrome

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Gastrostomy tube site complication

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Incision site impaired healing

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Incision site swelling

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Incisional hernia

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Inflammation of wound

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Injury

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Joint dislocation postoperative

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Kidney rupture

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Limb injury

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Meniscus injury

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Multiple fractures

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Pharyngeal injury

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Poisoning deliberate

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Post concussion syndrome

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Post procedural bile leak

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Post procedural diarrhoea

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Post procedural discharge

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Post procedural fever

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Post procedural swelling

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Post-traumatic pain

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Postoperative ileus

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Procedural haemorrhage

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Procedural shock

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Radius fracture

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Reactive gastropathy

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Scapula fracture

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Seroma

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Skin injury

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Skull fracture

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Soft tissue injury

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Spinal fracture

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Splenic rupture

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Subdural haemorrhage

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Tendon rupture

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Traumatic fracture

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Traumatic haematoma

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Unintentional medical device removal

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Upper limb fracture

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Vascular access complication

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Vascular access site rupture

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Wound complication

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Wound haemorrhage

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Injury, poisoning and procedural complications

Wrist fracture

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Investigations

Ammonia increased

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Investigations

Blood alkaline phosphatase increased

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Investigations

Ejection fraction decreased

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Investigations

Electrocardiogram QT prolonged

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Investigations

Haemoglobin decreased

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Investigations

Heart rate increased

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Investigations

Influenza B virus test positive

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Investigations

International normalised ratio increased

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Investigations

Liver function test abnormal

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Investigations

Respiratory syncytial virus test positive

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Metabolism and nutrition disorders

Diabetes mellitus

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Metabolism and nutrition disorders

Haemosiderosis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Metabolism and nutrition disorders

Hyperglycaemic hyperosmolar nonketotic syndrome

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Metabolism and nutrition disorders

Hyperphosphataemia

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Metabolism and nutrition disorders

Hypomagnesaemia

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Metabolism and nutrition disorders

Hypovolaemia

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Metabolism and nutrition disorders

Metabolic disorder

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Metabolism and nutrition disorders

Type 2 diabetes mellitus

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Arthritis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Bone metabolism disorder

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Bursitis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Chondrocalcinosis pyrophosphate

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Chronic kidney disease-mineral and bone disorder

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Compartment syndrome

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Costochondritis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Fracture nonunion

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Gouty arthritis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Haemarthrosis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Haematoma muscle

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Hungry bone syndrome

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Intervertebral disc degeneration

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Intervertebral disc protrusion

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Osteochondrosis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Osteoporosis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Pain in jaw

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Rhabdomyolysis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Spondylolysis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Systemic lupus erythematosus

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Musculoskeletal and connective tissue disorders

Trigger finger

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Adenocarcinoma pancreas

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Benign ovarian tumour

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bladder cancer recurrent

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bladder neoplasm

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Borderline ovarian tumour

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Breast cancer metastatic

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Carcinoid tumour

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Chronic lymphocytic leukaemia

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colorectal adenocarcinoma

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Endometrial adenocarcinoma

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Follicular thyroid cancer

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Genitourinary tract neoplasm

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Glioma

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Invasive lobular breast carcinoma

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Laryngeal cancer

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung cancer metastatic

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung carcinoma cell type unspecified stage IV

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung neoplasm

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung neoplasm malignant

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung squamous cell carcinoma metastatic

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Malignant melanoma

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Malignant neoplasm of pleura

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Meningioma benign

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Mixed hepatocellular cholangiocarcinoma

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Non-Hodgkin's lymphoma

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Non-small cell lung cancer

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Oesophageal adenocarcinoma stage II

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Pancreatic neoplasm

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Paraneoplastic syndrome

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Pelvic neoplasm

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Pleural mesothelioma malignant

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Prostate cancer stage II

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Rectal cancer

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Refractory cytopenia with unilineage dysplasia

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Renal adenoma

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Renal cancer metastatic

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Renal cell carcinoma stage I

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Sarcoma metastatic

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Small cell lung cancer metastatic

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Squamous cell carcinoma of the tongue

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Thyroid neoplasm

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Uterine leiomyoma

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Vulval cancer

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Vulval cancer metastatic

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Vulval cancer stage 0

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Amnesia

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Amputation stump pain

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Basal ganglia infarction

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Carotid artery aneurysm

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Central nervous system lupus

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Cerebellar stroke

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Cerebral artery occlusion

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Cerebral artery thrombosis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Cerebral microhaemorrhage

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Cervical radiculopathy

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Cognitive disorder

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Dementia

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Diabetic hyperosmolar coma

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Dyskinesia

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Epilepsy

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Facial paralysis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Focal dyscognitive seizures

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Guillain-Barre syndrome

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Headache

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Hemiparesis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Hyperammonaemic encephalopathy

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

IIIrd nerve paralysis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Jugular vein occlusion

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Lumbar radiculopathy

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Microvascular cranial nerve palsy

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Migraine

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Myelopathy

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Neuropathy peripheral

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Paraesthesia

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Partial seizures

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Post cardiac arrest syndrome

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Posterior reversible encephalopathy syndrome

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Postictal state

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Radiculopathy

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Spinal cord compression

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Trigeminal neuralgia

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Vasogenic cerebral oedema

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Nervous system disorders

Vertebral artery stenosis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Pregnancy, puerperium and perinatal conditions

Abortion spontaneous

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Pregnancy, puerperium and perinatal conditions

Breech presentation

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Pregnancy, puerperium and perinatal conditions

Cephalhaematoma

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Pregnancy, puerperium and perinatal conditions

Cervical incompetence

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Pregnancy, puerperium and perinatal conditions

Premature baby

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Product Issues

Device extrusion

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Product Issues

Device failure

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Product Issues

Device leakage

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Product Issues

Device physical property issue

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Product Issues

Patient-device incompatibility

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Psychiatric disorders

Acute psychosis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Psychiatric disorders

Acute stress disorder

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Psychiatric disorders

Alcohol abuse

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Psychiatric disorders

Alcohol withdrawal syndrome

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Psychiatric disorders

Completed suicide

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Psychiatric disorders

Delirium tremens

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Psychiatric disorders

Delusion

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Psychiatric disorders

Depression suicidal

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Psychiatric disorders

Hallucination, visual

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Psychiatric disorders

Major depression

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Psychiatric disorders

Post-traumatic stress disorder

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Psychiatric disorders

Substance abuse

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Psychiatric disorders

Suicide attempt

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Renal and urinary disorders

Cystitis haemorrhagic

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Renal and urinary disorders

Neurogenic bladder

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Renal and urinary disorders

Renal cyst ruptured

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Renal and urinary disorders

Renal haemorrhage

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Renal and urinary disorders

Renal impairment

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Renal and urinary disorders

Renal infarct

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Renal and urinary disorders

Renal mass

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Renal and urinary disorders

Renal tubular necrosis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Renal and urinary disorders

Ureteric obstruction

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Renal and urinary disorders

Urinary bladder rupture

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Reproductive system and breast disorders

Female genital tract fistula

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Reproductive system and breast disorders

Metrorrhagia

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Reproductive system and breast disorders

Ovarian cyst

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Reproductive system and breast disorders

Ovarian cyst ruptured

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Reproductive system and breast disorders

Pelvic fluid collection

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Reproductive system and breast disorders

Postmenopausal haemorrhage

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Reproductive system and breast disorders

Prostatitis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Reproductive system and breast disorders

Testicular oedema

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Reproductive system and breast disorders

Uterine haemorrhage

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Bronchospasm

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Cough

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Diaphragmatic disorder

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Hiccups

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Hypoventilation

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Interstitial lung disease

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Laryngeal oedema

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Lung opacity

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Pharyngeal oedema

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Pneumonitis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Productive cough

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Pulmonary alveolar haemorrhage

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Respiratory, thoracic and mediastinal disorders

Respiratory disorder

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Skin and subcutaneous tissue disorders

Blister

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Skin and subcutaneous tissue disorders

Cutaneous vasculitis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Skin and subcutaneous tissue disorders

Dermatitis contact

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Skin and subcutaneous tissue disorders

Hidradenitis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Skin and subcutaneous tissue disorders

Stevens-Johnson syndrome

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Skin and subcutaneous tissue disorders

Urticaria

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Social circumstances

Living in residential institution

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Surgical and medical procedures

Arteriovenous fistula operation

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Surgical and medical procedures

Cardiac pacemaker insertion

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Surgical and medical procedures

Haemodialysis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Surgical and medical procedures

Large intestinal polypectomy

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Surgical and medical procedures

Procoagulant therapy

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Surgical and medical procedures

Vascular access placement

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Accelerated hypertension

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Aortic dissection

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Arterial haemorrhage

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Arterial insufficiency

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Arterial occlusive disease

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Axillary vein thrombosis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Brachiocephalic vein stenosis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Circulatory collapse

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Distributive shock

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Embolism

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Embolism venous

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Iliac artery stenosis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Ischaemic limb pain

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Necrosis ischaemic

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Neurogenic shock

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Obstructive shock

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Peripheral artery aneurysm

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Peripheral embolism

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Post thrombotic syndrome

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Subclavian vein occlusion

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Subclavian vein stenosis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Subgaleal haemorrhage

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Superior vena cava stenosis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Thrombophlebitis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Vascular stenosis

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Vasculitis necrotising

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Vein rupture

0.06%

1/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.00%

0/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Vena cava thrombosis

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Vascular disorders

Venous thrombosis limb

0.00%

0/1768 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

0.06%

1/1769 • Up to 170 weeks

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Measure	Vadadustat n=1768 participants at risk Participants were randomized to receive Vadadustat at an initial oral dose of 300 milligrams per day (mg/day). Thereafter, Vadadustat was taken once daily on an outpatient basis. Up-and-down titration to 150, 300, 450, and 600 mg (available tablet strength was administered as the appropriate number of 150 mg tablets) was allowed during the study based on hemoglobin (Hb) level measurements to maintain target Hb levels.	Darbepoetin Alfa n=1769 participants at risk Participants were randomized to Darbepoetin alfa at an initial dose that was based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics (SmPC) for all other investigational sites (non-US) for adult participants with chronic kidney disease on dialysis. For participants already on Darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.
Vascular disorders Hypertension	9.9% 175/1768 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.	13.1% 232/1769 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.
Gastrointestinal disorders Diarrhoea	12.8% 226/1768 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.	9.8% 173/1769 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.
Nervous system disorders Headache	9.0% 160/1768 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.	7.6% 134/1769 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.
Injury, poisoning and procedural complications Fall	7.7% 136/1768 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.	8.1% 144/1769 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.
Gastrointestinal disorders Nausea	8.4% 148/1768 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.	7.4% 131/1769 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.
Metabolism and nutrition disorders Hyperkalaemia	7.0% 123/1768 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.	7.7% 137/1769 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.
Vascular disorders Hypotension	7.0% 124/1768 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.	6.7% 119/1769 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.
Gastrointestinal disorders Vomiting	6.7% 119/1768 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.	7.0% 123/1769 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.
Injury, poisoning and procedural complications Dialysis related complication	5.6% 99/1768 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.	6.9% 122/1769 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.
Respiratory, thoracic and mediastinal disorders Cough	5.6% 99/1768 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.	6.8% 120/1769 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.
Infections and infestations Upper respiratory tract infection	5.5% 98/1768 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.	6.1% 108/1769 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	4.8% 84/1768 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.	6.4% 113/1769 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.
Infections and infestations Urinary tract infection	5.7% 100/1768 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.	5.3% 93/1769 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.5% 79/1768 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.	6.3% 111/1769 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.
Injury, poisoning and procedural complications Arteriovenous fistula site complication	4.5% 80/1768 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.	6.0% 107/1769 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.
Infections and infestations Nasopharyngitis	5.2% 92/1768 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.	4.7% 84/1769 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.
Musculoskeletal and connective tissue disorders Back pain	4.0% 71/1768 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.	5.2% 92/1769 • Up to 170 weeks Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0017 (NCT02892149). Of the participants randomized, 3537 participants were included in the Safety population (1768 and 1769 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). 17 randomized participants did not receive treatment.

Trial Outcomes & Findings for Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Dialysis-dependent Chronic Kidney Disease (DD-CKD) (NCT NCT02892149)

Results Overview

Participant Flow

Participant milestones

Reasons for withdrawal

Baseline Characteristics

Baseline characteristics by cohort

PRIMARY outcome

Outcome measures

PRIMARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

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SECONDARY outcome

Outcome measures

OTHER_PRE_SPECIFIED outcome

Outcome measures

OTHER_PRE_SPECIFIED outcome

Outcome measures

OTHER_PRE_SPECIFIED outcome

Outcome measures

OTHER_PRE_SPECIFIED outcome

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OTHER_PRE_SPECIFIED outcome

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OTHER_PRE_SPECIFIED outcome

Outcome measures

OTHER_PRE_SPECIFIED outcome

Outcome measures

OTHER_PRE_SPECIFIED outcome

Outcome measures

OTHER_PRE_SPECIFIED outcome

Outcome measures

OTHER_PRE_SPECIFIED outcome

Outcome measures

Adverse Events

Vadadustat

Darbepoetin Alfa

Serious adverse events

Other adverse events

Additional Information

Clinical Trial Information Desk

Results disclosure agreements