Trial Outcomes & Findings for Study to Evaluate Vadadustat for the Correction of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease (NCT NCT02648347)
NCT ID: NCT02648347
Last Updated: 2022-06-27
Results Overview
The Baseline average was calculated as the average of the Hb values obtained at the screening visit closest to the date of randomization and the randomization visit. The average for the Primary Efficacy Period was calculated as the average Hb value over Weeks 24 to 36. Analysis was conducted using an analysis of covariance (ANCOVA) model with multiple imputation for missing data with Baseline Hb concentration (\<9.5 versus ≥9.5 grams per deciliter \[g/dL\]), geographic region (United States \[US\] versus European Union \[EU\] versus Rest of World \[ROW\]), and New York Heart Association congestive heart failure (NYHA CHF) class (Class 0 \[no CHF\] or I versus II or III) as covariates.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1751 participants
Primary outcome timeframe
Baseline; Weeks 24 to 36
Results posted on
2022-06-27
Participant Flow
A total of 4708 participants were screened for entry into the study. Of these, 1751 participants were enrolled and randomized into the study.
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 not on dialysis.
|
|---|---|---|
|
Overall Study
STARTED
|
879
|
872
|
|
Overall Study
COMPLETED
|
670
|
675
|
|
Overall Study
NOT COMPLETED
|
209
|
197
|
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 not on dialysis.
|
|---|---|---|
|
Overall Study
Death
|
174
|
167
|
|
Overall Study
Withdrawal by Subject
|
16
|
9
|
|
Overall Study
Lost to Follow-up
|
18
|
21
|
|
Overall Study
Missing
|
1
|
0
|
Baseline Characteristics
Study to Evaluate Vadadustat for the Correction of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
Vadadustat
n=879 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=872 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 not on dialysis.
|
Total
n=1751 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.2 Years
STANDARD_DEVIATION 14.27 • n=5 Participants
|
64.9 Years
STANDARD_DEVIATION 13.71 • n=7 Participants
|
65.0 Years
STANDARD_DEVIATION 13.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
475 Participants
n=5 Participants
|
506 Participants
n=7 Participants
|
981 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
404 Participants
n=5 Participants
|
366 Participants
n=7 Participants
|
770 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
48 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
188 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
360 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
546 Participants
n=5 Participants
|
571 Participants
n=7 Participants
|
1117 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Reported as Other
|
58 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Mean hemoglobin
|
9.113 Grams per deciliter (g/dL)
STANDARD_DEVIATION 0.8015 • n=5 Participants
|
9.142 Grams per deciliter (g/dL)
STANDARD_DEVIATION 0.7790 • n=7 Participants
|
9.128 Grams per deciliter (g/dL)
STANDARD_DEVIATION 0.7903 • n=5 Participants
|
|
Mean estimated glomerular filtration rate
|
21.2 mL/min/1.73m^2
STANDARD_DEVIATION 11.99 • n=5 Participants
|
21.9 mL/min/1.73m^2
STANDARD_DEVIATION 12.60 • n=7 Participants
|
21.5 mL/min/1.73m^2
STANDARD_DEVIATION 12.30 • n=5 Participants
|
|
Number of Participants with History of Diabetes
|
507 Participants
n=5 Participants
|
514 Participants
n=7 Participants
|
1021 Participants
n=5 Participants
|
|
Number of Participants with NYHA Functional Classification of Heart Failure
NYHA Class 0
|
613 Participants
n=5 Participants
|
601 Participants
n=7 Participants
|
1214 Participants
n=5 Participants
|
|
Number of Participants with NYHA Functional Classification of Heart Failure
NYHA Class I
|
136 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
259 Participants
n=5 Participants
|
|
Number of Participants with NYHA Functional Classification of Heart Failure
NYHA Class II
|
100 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
219 Participants
n=5 Participants
|
|
Number of Participants with NYHA Functional Classification of Heart Failure
NYHA Class III
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Number of Participants with NYHA Functional Classification of Heart Failure
NYHA Class IV
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Number of Participants with NYHA Functional Classification of Heart Failure
NYHA Class Missing
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Number of Participants with Any History of Heart Failure
Yes
|
36 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Number of Participants with Any History of Heart Failure
No
|
624 Participants
n=5 Participants
|
609 Participants
n=7 Participants
|
1233 Participants
n=5 Participants
|
|
Number of Participants with Any History of Heart Failure
Missing
|
219 Participants
n=5 Participants
|
225 Participants
n=7 Participants
|
444 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline; Weeks 24 to 36Population: Randomized Population: All participants randomized. Analyses of this population were based on the randomized treatment.
The Baseline average was calculated as the average of the Hb values obtained at the screening visit closest to the date of randomization and the randomization visit. The average for the Primary Efficacy Period was calculated as the average Hb value over Weeks 24 to 36. Analysis was conducted using an analysis of covariance (ANCOVA) model with multiple imputation for missing data with Baseline Hb concentration (\<9.5 versus ≥9.5 grams per deciliter \[g/dL\]), geographic region (United States \[US\] versus European Union \[EU\] versus Rest of World \[ROW\]), and New York Heart Association congestive heart failure (NYHA CHF) class (Class 0 \[no CHF\] or I versus II or III) as covariates.
Outcome measures
| Measure |
Vadadustat
n=879 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=872 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 not on dialysis.
|
|---|---|---|
|
Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36)
|
1.43 g/dL
Standard Error 0.046
|
1.38 g/dL
Standard Error 0.047
|
PRIMARY outcome
Timeframe: Up to Week 208Population: Safety Population (PRO2TECT): All participants from the PRO2TECT (Non-dialysis-dependent chronic kidney disease \[NDD-CKD\]) population who received 1 or more doses of study drug. Only those participants with MACE events were analyzed for this outcome measure.
MACE was defined as all-cause mortality, non-fatal myocardial infarction (MI), or non-fatal stroke. The primary safety outcome was positively adjudicated first MACE, which was defined as any death, Endpoint Adjudication Committee (EAC)-confirmed non-fatal MI, or EAC-confirmed non-fatal stroke occurring between the first dose date and each participant's last participation date. PROTECT MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Results and statistical analysis from study AKB-6548-CI-0014 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0014 and AKB-6548-CI-0015 has been reported under section "Statistical Analysis 2" of this outcome measure.
Outcome measures
| Measure |
Vadadustat
n=214 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=192 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 not on dialysis.
|
|---|---|---|
|
Median Time to First Major Adverse Cardiovascular Event (MACE)
|
45.71 Weeks
Interval 21.71 to 83.14
|
46.71 Weeks
Interval 25.93 to 85.57
|
SECONDARY outcome
Timeframe: Baseline; Weeks 40 to 52Population: Randomized Population
The Baseline average was calculated as the average of the Hb values obtained at the screening visit closest to the date of randomization and the randomization visit. The average for the Secondary Efficacy Period was calculated as the average Hb value over Weeks 40 to 52. Analysis was conducted using an ANCOVA model with multiple imputation for missing data with Baseline Hb concentration (\<9.5 versus ≥9.5 g/dL), geographic region (US versus EU versus ROW), and NYHA CHF class (Class 0 \[no CHF\] or I versus II or III) as covariates.
Outcome measures
| Measure |
Vadadustat
n=879 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=872 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 not on dialysis.
|
|---|---|---|
|
Change From Baseline in Hb to the Average Over the Secondary Efficacy Period (Weeks 40 to 52)
|
1.52 g/dL
Standard Error 0.052
|
1.48 g/dL
Standard Error 0.053
|
SECONDARY outcome
Timeframe: Up to Week 208Population: Safety Population (PRO2TECT). Only those participants with MACE plus hospitalization for heart failure or thromboembolic event excluding vascular access thrombosis were analyzed for this outcome measure.
MACE was defined as all-cause mortality, non-fatal MI, or non-fatal stroke. Hospitalization for EAC adjudicated heart failure included presentation of participants to an acute care facility requiring an overnight hospitalization (change in calendar day) with an exacerbation of heart failure requiring treatment. EAC confirmed thromboembolic events for this secondary outcome measure included arterial thrombosis, deep vein thrombosis, and pulmonary embolism. PROTECT MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Results and statistical analysis from study AKB-6548-CI-0014 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0014 and AKB-6548-CI-0015 has been reported under section "Statistical Analysis 2" of this outcome measure.
Outcome measures
| Measure |
Vadadustat
n=254 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=229 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 not on dialysis.
|
|---|---|---|
|
Median Time to First MACE Plus Hospitalization for Heart Failure or Thromboembolic Event Excluding Vascular Access Thrombosis
|
37.64 Weeks
Interval 17.14 to 74.14
|
41.43 Weeks
Interval 21.71 to 75.14
|
SECONDARY outcome
Timeframe: Up to Week 208Population: Safety Population (PRO2TECT). Only those participants with cardiovascular MACE events were analyzed for this outcome measure.
MACE was defined as all-cause mortality, non-fatal MI, or non-fatal stroke. Cardiovascular MACE analysis differed from the primary MACE endpoint as it included only deaths adjudicated by the EAC as cardiovascular deaths (i.e, only EAC-confirmed cardiovascular deaths) in addition to first events of non-fatal MI or non-fatal stroke. PROTECT MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Results and statistical analysis from study AKB-6548-CI-0014 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0014 and AKB-6548-CI-0015 has been reported under section "Statistical Analysis 2" of this outcome measure.
Outcome measures
| Measure |
Vadadustat
n=109 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=95 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 not on dialysis.
|
|---|---|---|
|
Median Time to First Cardiovascular MACE
|
45.86 Weeks
Interval 22.29 to 78.86
|
41.86 Weeks
Interval 20.29 to 90.0
|
SECONDARY outcome
Timeframe: Up to Week 208Population: Safety Population (PRO2TECT). Only those participants with cardiovascular death were analyzed for this outcome measure.
Cardiovascular death included EAC adjudicated fatal MI, pump failure, sudden death, presumed sudden death, fatal stroke, fatal pulmonary embolism, cardiovascular procedure-related death, other cardiovascular death, and presumed cardiovascular death. PROTECT MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Results and statistical analysis from study AKB-6548-CI-0014 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0014 and AKB-6548-CI-0015 has been reported under section "Statistical Analysis 2" of this outcome measure.
Outcome measures
| Measure |
Vadadustat
n=71 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=65 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 not on dialysis.
|
|---|---|---|
|
Median Time to First Cardiovascular Death
|
48.29 Weeks
Interval 28.86 to 83.14
|
41.86 Weeks
Interval 16.0 to 92.29
|
SECONDARY outcome
Timeframe: Up to Week 208Population: Safety Population (PRO2TECT). Only those participants with all-cause mortality were analyzed for this outcome measure.
Only events that were positively adjudicated and confirmed by the EAC were included in the MACE analyses. PROTECT MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Results and statistical analysis from study AKB-6548-CI-0014 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0014 and AKB-6548-CI-0015 has been reported under section "Statistical Analysis 2" of this outcome measure.
Outcome measures
| Measure |
Vadadustat
n=180 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=168 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 not on dialysis.
|
|---|---|---|
|
Median Time to First All-cause Mortality
|
46.57 Weeks
Interval 22.29 to 84.36
|
47.79 Weeks
Interval 27.36 to 88.79
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Weeks 24 to 36Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Weeks 24 to 36Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Weeks 40 to 52Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Weeks 40 to 52Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline; up to Week 52Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline; up to Week 52Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline; Weeks 24 to 36Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 52Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 52Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 52Outcome measures
Outcome data not reported
Adverse Events
Vadadustat
Serious events: 573 serious events
Other events: 561 other events
Deaths: 180 deaths
Darbepoetin Alfa
Serious events: 561 serious events
Other events: 565 other events
Deaths: 168 deaths
Serious adverse events
| Measure |
Vadadustat
n=878 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=870 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 not on dialysis.
|
|---|---|---|
|
Renal and urinary disorders
End stage renal disease
|
33.3%
292/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
33.6%
292/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Pneumonia
|
6.8%
60/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
5.6%
49/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.8%
42/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
4.6%
40/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
4.6%
40/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
4.5%
39/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
3.6%
32/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
3.1%
27/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Fluid overload
|
3.9%
34/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
2.5%
22/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Sepsis
|
3.2%
28/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
2.2%
19/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.3%
20/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
3.0%
26/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Cardiac failure acute
|
2.4%
21/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
2.8%
24/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.1%
18/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
2.8%
24/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
General disorders
Death
|
2.6%
23/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
2.2%
19/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Cardiac arrest
|
2.6%
23/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
1.8%
16/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.1%
18/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
2.3%
20/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.7%
15/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
2.1%
18/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Urinary tract infection
|
2.2%
19/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
1.5%
13/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Cellulitis
|
1.8%
16/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
1.5%
13/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Cardiac failure
|
1.7%
15/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
1.4%
12/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Coronary artery disease
|
1.4%
12/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
1.4%
12/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.7%
15/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
1.0%
9/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Septic shock
|
1.4%
12/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
1.3%
11/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.0%
9/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
1.4%
12/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
12/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
1.0%
9/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.0%
9/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
1.4%
12/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.91%
8/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
1.5%
13/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.1%
10/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
1.1%
10/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.91%
8/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
1.4%
12/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Hypertensive urgency
|
1.0%
9/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
1.3%
11/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
1.3%
11/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.92%
8/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Metabolic encephalopathy
|
1.0%
9/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
1.1%
10/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.80%
7/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
1.3%
11/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.91%
8/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
1.0%
9/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Peritonitis
|
1.0%
9/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.92%
8/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
Azotaemia
|
0.91%
8/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
1.0%
9/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
1.4%
12/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.46%
4/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Hypertension
|
0.68%
6/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
1.1%
10/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.46%
4/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
1.3%
11/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
1.0%
9/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.69%
6/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.68%
6/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
1.0%
9/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Gastroenteritis
|
1.0%
9/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.57%
5/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Osteomyelitis
|
0.68%
6/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.92%
8/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Urosepsis
|
0.80%
7/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.80%
7/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Syncope
|
0.80%
7/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.80%
7/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.57%
5/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.92%
8/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Gangrene
|
0.80%
7/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.69%
6/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.91%
8/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.57%
5/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Hypertensive emergency
|
0.46%
4/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
1.0%
9/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Hypotension
|
0.68%
6/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.80%
7/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.0%
9/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.34%
3/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.57%
5/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.80%
7/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Angina unstable
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.92%
8/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Investigations
Transaminases increased
|
0.80%
7/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.46%
4/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.68%
6/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.57%
5/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Ischaemic stroke
|
0.57%
5/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.69%
6/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Uraemic encephalopathy
|
0.80%
7/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.46%
4/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.57%
5/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.69%
6/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.68%
6/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.57%
5/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.57%
5/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.57%
5/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.46%
4/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.69%
6/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
Renal failure
|
1.0%
9/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.57%
5/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.57%
5/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
General disorders
Asthenia
|
1.0%
9/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.68%
6/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.34%
3/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Influenza
|
0.68%
6/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.34%
3/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.80%
7/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.68%
6/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.34%
3/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.68%
6/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.34%
3/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.57%
5/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Cardiogenic shock
|
0.68%
6/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.80%
7/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.57%
5/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.34%
3/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.69%
6/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.46%
4/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.46%
4/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Psychiatric disorders
Mental status changes
|
0.46%
4/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.46%
4/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Hypertensive crisis
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.69%
6/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.46%
4/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.46%
4/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.57%
5/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Left ventricular failure
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.69%
6/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.46%
4/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.46%
4/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.34%
3/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Bronchitis
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.46%
4/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Pneumonia bacterial
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.57%
5/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Pyelonephritis
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.57%
5/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.46%
4/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.46%
4/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.57%
5/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.68%
6/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Device related infection
|
0.57%
5/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Diverticulitis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.57%
5/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.57%
5/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.34%
3/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.57%
5/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.34%
3/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Gout
|
0.46%
4/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.34%
3/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.46%
4/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.69%
6/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.46%
4/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Peripheral ischaemia
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.34%
3/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
General disorders
Generalised oedema
|
0.46%
4/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.46%
4/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Bacteraemia
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Localised infection
|
0.46%
4/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Postoperative wound infection
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.34%
3/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.34%
3/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.57%
5/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.46%
4/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.46%
4/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.46%
4/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Product Issues
Device occlusion
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
Hypertensive nephropathy
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.34%
3/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.34%
3/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.34%
3/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Atrial flutter
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Bradycardia
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.34%
3/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.46%
4/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.34%
3/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Uraemic gastropathy
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Abscess limb
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.34%
3/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Arthritis bacterial
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Cystitis
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Diabetic foot infection
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.34%
3/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Pyelonephritis acute
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.34%
3/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Pyelonephritis chronic
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.34%
3/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.34%
3/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Investigations
Hepatic enzyme increased
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.34%
3/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.34%
3/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Brain injury
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.34%
3/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Product Issues
Device dislocation
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.34%
3/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.34%
3/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Arrhythmia
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.34%
3/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Congenital, familial and genetic disorders
Gastrointestinal arteriovenous malformation
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Haematemesis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
General disorders
Chest pain
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Clostridium difficile infection
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Peritonitis bacterial
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Pulmonary sepsis
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Viral infection
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.34%
3/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Calciphylaxis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Cerebral infarction
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Dizziness
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Embolic stroke
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Encephalopathy
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.34%
3/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Seizure
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
Glomerulonephritis chronic
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Extremity necrosis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Shock haemorrhagic
|
0.34%
3/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Steal syndrome
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Atrial thrombosis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Cardiomyopathy
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Eye disorders
Retinal vein thrombosis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Enteritis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Haematochezia
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
General disorders
Catheter site haemorrhage
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
General disorders
Device related thrombosis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
General disorders
Peripheral swelling
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
General disorders
Sudden death
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Arteriovenous fistula site infection
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Cellulitis gangrenous
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Cystitis klebsiella
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Device related sepsis
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Endocarditis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Gas gangrene
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Hepatitis C
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Infected skin ulcer
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Osteomyelitis acute
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Rhinovirus infection
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Staphylococcal infection
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Wound sepsis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Investigations
Troponin increased
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelofibrosis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Dysarthria
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Lacunar infarction
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Tremor
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
Renal impairment
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Accelerated hypertension
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Diabetic vascular disorder
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.23%
2/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Dry gangrene
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Haematoma
|
0.23%
2/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Blood and lymphatic system disorders
Leukaemoid reaction
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Adams-Stokes syndrome
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Bundle branch block
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Cardiac tamponade
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Cardiac valve disease
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Chronic left ventricular failure
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Pericarditis uraemic
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Systolic dysfunction
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Endocrine disorders
Goitre
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Eye disorders
Blindness
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Eye disorders
Cataract
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Eye disorders
Macular degeneration
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Eye disorders
Uveitis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Eye disorders
Vision blurred
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Cyclic vomiting syndrome
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Dieulafoy's vascular malformation
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Gastric antral vascular ectasia
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Gastric varices haemorrhage
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Haemoperitoneum
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Haemorrhagic erosive gastritis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Oesophageal ulcer haemorrhage
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Pancreatic necrosis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
General disorders
Accidental death
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
General disorders
Cardiac death
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
General disorders
Chest discomfort
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
General disorders
Complication of device insertion
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
General disorders
Fatigue
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
General disorders
Hypothermia
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
General disorders
Impaired healing
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
General disorders
Malaise
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
General disorders
Oedema
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
General disorders
Pyrexia
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
General disorders
Sudden cardiac death
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Hepatobiliary disorders
Non-alcoholic steatohepatitis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Immune system disorders
Anti-neutrophil cytoplasmic antibody positive vasculitis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Immune system disorders
Renal transplant failure
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Abdominal sepsis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Abdominal wall abscess
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Abscess
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Abscess neck
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Acute hepatitis C
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Appendicitis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Arteriovenous graft site infection
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Arthritis infective
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Bacterial sepsis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Catheter bacteraemia
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Chronic hepatitis B
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Diarrhoea infectious
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Ear infection
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Emphysematous cystitis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Encephalitis brain stem
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Encephalitis viral
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Endocarditis bacterial
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Endocarditis staphylococcal
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Endophthalmitis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Escherichia pyelonephritis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Furuncle
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Gastroenteritis clostridial
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Groin abscess
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
H1N1 influenza
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Hepatitis B
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Immune reconstitution inflammatory syndrome associated tuberculosis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Infected fistula
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Liver abscess
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Medical device site joint infection
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Necrotising soft tissue infection
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Overgrowth bacterial
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Parotitis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Perineal abscess
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Pharyngitis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Pneumonia cryptococcal
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Prostatic abscess
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Scrotal abscess
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Staphylococcal abscess
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Stoma site cellulitis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Urogenital infection bacterial
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Viral sepsis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Wound abscess
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Wound infection
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula aneurysm
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Iatrogenic injury
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Keratorhexis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Lisfranc fracture
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Pelvic bone injury
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Peritoneal dialysis complication
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Postpericardiotomy syndrome
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Pulmonary contusion
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Urinary tract stoma complication
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Vascular access malfunction
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Vascular access site pseudoaneurysm
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Vascular injury
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Vulvovaginal injury
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Investigations
Arteriogram carotid abnormal
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Investigations
Blood creatine increased
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Investigations
Blood glucose decreased
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Investigations
Blood pressure increased
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Investigations
Heart rate irregular
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Investigations
Hepatic enzyme abnormal
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Investigations
Liver function test abnormal
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Investigations
Pulmonary arterial pressure increased
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Hyperosmolar state
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Hypoosmolar state
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Vitamin B1 deficiency
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Musculoskeletal and connective tissue disorders
Haematoma muscle
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma, low grade
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric leiomyoma
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papillary mucinous neoplasm
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified recurrent
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Marginal zone lymphoma
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic bronchial carcinoma
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal squamous cell carcinoma stage 0
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary renal cell carcinoma
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma recurrent
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer stage IV
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Altered state of consciousness
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Ataxia
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Autonomic neuropathy
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Basal ganglia infarction
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Brain oedema
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Brain stem haemorrhage
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Brain stem stroke
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Cerebellar stroke
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Cerebral small vessel ischaemic disease
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Coma
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Focal dyscognitive seizures
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Hypoglycaemic encephalopathy
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Hypoglycaemic seizure
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Hyponatraemic seizure
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Migraine
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Radiculopathy
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
VIth nerve paralysis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Vascular dementia
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Product Issues
Device adhesion issue
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Product Issues
Device malfunction
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Psychiatric disorders
Bipolar disorder
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Psychiatric disorders
Depression
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Psychiatric disorders
Psychotic disorder
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
Bladder outlet obstruction
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
Bladder perforation
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
Glomerulonephritis rapidly progressive
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
Hydroureter
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
IgA nephropathy
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
Lupus nephritis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
Nephritic syndrome
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
Obstructive nephropathy
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
Post infection glomerulonephritis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
Renal mass
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
Renal tubular acidosis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Reproductive system and breast disorders
Varicocele
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Non-cardiogenic pulmonary oedema
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Skin and subcutaneous tissue disorders
Diabetic wound
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Social circumstances
Physical disability
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Surgical and medical procedures
Arteriovenous fistula operation
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Aortic rupture
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Essential hypertension
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Haemorrhage
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Iliac artery perforation
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Internal haemorrhage
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Malignant hypertension
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Shock
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Subclavian artery stenosis
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Vasculitis
|
0.11%
1/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.00%
0/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Venous perforation
|
0.00%
0/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
0.11%
1/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
Other adverse events
| Measure |
Vadadustat
n=878 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=870 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 not on dialysis.
|
|---|---|---|
|
Vascular disorders
Hypertension
|
17.2%
151/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
21.4%
186/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
10.6%
93/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
13.9%
121/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.0%
114/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
9.8%
85/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
General disorders
Oedema peripheral
|
12.5%
110/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
10.2%
89/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Urinary tract infection
|
11.2%
98/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
10.8%
94/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Nausea
|
9.9%
87/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
8.2%
71/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
8.4%
74/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
9.2%
80/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Constipation
|
8.4%
74/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
8.3%
72/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
7.3%
64/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
7.2%
63/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.7%
50/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
8.0%
70/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
60/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
6.0%
52/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
7.2%
63/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
5.5%
48/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.4%
47/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
6.7%
58/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Fluid overload
|
5.1%
45/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
6.3%
55/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.3%
55/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
5.2%
45/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Nasopharyngitis
|
5.7%
50/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
5.5%
48/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.2%
46/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
6.0%
52/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Vascular disorders
Hypotension
|
5.6%
49/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
5.6%
49/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.1%
45/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
5.4%
47/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Headache
|
5.2%
46/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
4.8%
42/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Nervous system disorders
Dizziness
|
5.1%
45/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
3.9%
34/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
|
Infections and infestations
Bronchitis
|
3.2%
28/878 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
|
5.3%
46/870 • Up to 208 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported in study AKB-6548-CI-0014 (NCT02648347). Of the participants randomized, 1748 participants were included in the Safety population (878 and 870 participants in the Vadadustat and Darbepoetin alfa treatment groups, respectively). Three randomized participants did not receive treatment.
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Additional Information
Clinical Trial Information Desk
Akebia Therapeutics, Inc.
Phone: +1 617-844-6128
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place