Study of Roxadustat in Non-Dialysis Chronic Kidney Diseas... | NCT01244763

Name	Class
Astellas Pharma Inc	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort A: Roxadustat Tiered, Weight Based Dosing TIW	Experimental	Participants will receive roxadustat capsules, administered orally 3 times weekly (TIW) for 16 weeks. Initial roxadustat dose will be based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kilograms (kg)], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants will receive 60, 100, and 140 milligrams [mg] roxadustat, respectively). Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.	Drug: Roxadustat
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW then BIW	Experimental	Participants will receive roxadustat capsules orally for 16 weeks. Initial roxadustat dose will be based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants will receive 60, 100, and 140 mg roxadustat, respectively). Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants will have a dose frequency reduction from TIW to 2 times a week (BIW) at the time of the initial Hb response.	Drug: Roxadustat
Cohort C: Roxadustat at 50 mg TIW	Experimental	Participants will receive roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.	Drug: Roxadustat
Cohort D: Roxadustat at 100 mg TIW

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Roxadustat	Drug	Oral capsule	Cohort A: Roxadustat Tiered, Weight Based Dosing TIW Cohort B: Roxadustat Tiered, Weight Based Dosing TIW then BIW Cohort C: Roxadustat at 50 mg TIW

Measure	Description	Time Frame
Number (%) of Participants With an Hb Response by Week 17	An Hb response was defined as a Hb level of ≥11 g/dL and an increase from BL ≥1 g/dL.	Up to Week 17

Measure	Description	Time Frame
Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25	An Hb response was defined as a Hb level of ≥11 g/dL and an increase from BL ≥1 g/dL.	Up to Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)
Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25

Eligibility Module

PubMed Identifier	Type	Citation	Retractions
36005278	Derived	Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.

ID	Title	Description
FG000	Cohort A: Roxadustat Tiered, Weight Based Dosing TIW	Participants received roxadustat capsules, administered orally 3 times weekly (TIW) for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kilograms (kg)], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 milligrams [mg] roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.

Arm/Group Information

ID	Title	Description
BG000	Cohort A: Roxadustat Tiered, Weight Based Dosing TIW	Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
BG001	Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW	Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.
BG002	Cohort C: Roxadustat at 50 mg TIW	Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
BG003	Cohort D: Roxadustat at 100 mg TIW	Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
BG004	Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW	Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response.
BG005	Cohort F: Roxadustat at 70 mg BIW Then QW	Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency was reduced from BIW to QW.
BG006	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number (%) of Participants With an Hb Response by Week 17

An Hb response was defined as a Hb level of ≥11 g/dL and an increase from BL ≥1 g/dL.

EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study.

Posted

Count of Participants

Participants

Up to Week 17

ID	Title	Description
OG000	Cohort A: Roxadustat Tiered, Weight Based Dosing TIW	Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
OG001	Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW	Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.
OG002	Cohort C: Roxadustat at 50 mg TIW	Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
OG003	Cohort D: Roxadustat at 100 mg TIW	Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
OG004	Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW	Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response.
OG005	Cohort F: Roxadustat at 70 mg BIW Then QW	Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency was reduced from BIW to QW.

Units	Counts
Participants	OG00023 OG00124 OG00223 OG003

Title

Denominators

Categories

Title	Measurements
	OG00019 OG00124 OG00221 OG003

Secondary

Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25

An Hb response was defined as a Hb level of ≥11 g/dL and an increase from BL ≥1 g/dL.

EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint.

Posted

Count of Participants

Participants

Up to Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)

ID	Title	Description
OG000	Cohort A: Roxadustat Tiered, Weight Based Dosing TIW	Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
OG001	Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW	Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.

Secondary

Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25

Baseline is defined as the mean of the last 3 available values predose.

Posted

Mean

Standard Deviation

g/dL

Baseline, Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)

ID	Title	Description
OG000	Cohort A: Roxadustat Tiered, Weight Based Dosing TIW	Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
OG001	Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW	Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.

Secondary

Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28

Participants can have a Hb value reported for more than 1 of the categories (11-12, 11-13, and 10.5-13 g/dL) during the week intervals since these categories are not mutually exclusive.

Posted

Count of Participants

Participants

Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only)

ID	Title	Description
OG000	Cohort A: Roxadustat Tiered, Weight Based Dosing TIW	Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
OG001	Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW	Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.

Secondary

Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28

Posted

Count of Participants

Participants

Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only)

ID	Title	Description
OG000	Cohort A: Roxadustat Tiered, Weight Based Dosing TIW	Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
OG001	Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW	Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.

Secondary

Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25

Participants can have a Hb value for the same category (11-12, 11-13, or 10.5-13 g/dL) reported for multiple weeks.

Posted

Count of Participants

Participants

Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)

ID	Title	Description
OG000	Cohort A: Roxadustat Tiered, Weight Based Dosing TIW	Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
OG001	Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW	Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.

Secondary

Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28

Posted

Count of Participants

Participants

Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only)

ID	Title	Description
OG000	Cohort A: Roxadustat Tiered, Weight Based Dosing TIW	Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
OG001	Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW	Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.

Secondary

Median Time to Hb Response: Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL

Median time to response was estimated using Kaplan Meier method, Cohort A and B censored at Week 17, Cohort C, D, E, and F censored at Week 25. The median number of days presented was calculated from Baseline to the day the Hb response was achieved.

EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study.

Posted

Median

Full Range

days

Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C-F)

ID	Title	Description
OG000	Cohort A: Roxadustat Tiered, Weight Based Dosing TIW	Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
OG001	Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW	Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.

Secondary

Median Initial Hb Responsive Time: Time to Initial Hb Increase ≥1.0 g/dL From Baseline

Median time to response was estimated using Kaplan Meier method; Cohort A and B censored at Week 17 and Cohort C, D, E, and F censored at Week 25. The median number of days presented was calculated from Baseline to the day the Hb response was achieved.

EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study.

Posted

Median

Full Range

days

Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C, D, E, and F)

ID	Title	Description
OG000	Cohort A: Roxadustat Tiered, Weight Based Dosing TIW	Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
OG001	Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW	Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.

Secondary

Median Initial Hb Responsive Dose: Dose at Which Initial Hb Increases to ≥1.0 g/dL From Baseline

EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study.

Posted

Median

Full Range

mg/kg/week

Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C-F)

ID	Title	Description
OG000	Cohort A: Roxadustat Tiered, Weight Based Dosing TIW	Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
OG001	Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW	Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.

Secondary

Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week

EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified timepoint.

Posted

Mean

Standard Deviation

g/dL

Cohorts A and B: Weekly through Week 16 (end of treatment), Week 18 (2 weeks posttreatment), and Week 20 (4 weeks posttreatment); Cohorts C-F: Weekly through Week 24 (end of treatment), Week 26 (2 weeks posttreatment), and Week 28 (4 weeks posttreatment)

ID	Title	Description
OG000	Cohort A: Roxadustat Tiered, Weight Based Dosing TIW	Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
OG001	Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW	Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.

Secondary

Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories

Posted

Mean

Standard Deviation

g/dL

Cohorts A and B: Weekly through Week 16 (end of treatment [EoT]) and Week 20 (Follow up [4 weeks posttreatment]); Cohorts C-F: Weekly through Week 24 (EoT) and Week 28 (Follow up [4 weeks posttreatment])

ID	Title	Description
OG000	Cohort A: Roxadustat Tiered, Weight Based Dosing TIW	Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
OG001	Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW	Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.

Secondary

Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25

The mean percentage of the scheduled weekly Hb values that were <10.5, >13, and >14 g/dL during Weeks 13-17 and 18-25 is presented.

Posted

Mean

Standard Deviation

percentage of Hb values

Weeks 13-17 (all cohorts) and 18-25 (24-week treatment cohorts only)

ID	Title	Description
OG000	Cohort A: Roxadustat Tiered, Weight Based Dosing TIW	Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
OG001	Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW	Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.

Secondary

Number (%) of Participants Requiring Rescue Therapy

Rescue treatment included recombinant erythropoiesis-stimulating agent (ESA), red blood cell transfusion (in the absence of a known bleeding episode or surgical blood loss), or intravenous (IV) Iron

Safety Population included all participants who received any dose of study drug.

Posted

Count of Participants

Participants

Baseline up to Week 28 (end of study)

ID	Title	Description
OG000	Cohort A: Roxadustat Tiered, Weight Based Dosing TIW	Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
OG001	Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW	Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.

Secondary

Number (%) of Participants Requiring Therapeutic Phlebotomy

Safety Population included all participants who received any dose of study drug.

Posted

Count of Participants

Participants

Baseline up to Week 28 (end of study)

ID	Title	Description
OG000	Cohort A: Roxadustat Tiered, Weight Based Dosing TIW	Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
OG001	Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW	Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.

Secondary

Number (%) of Participants Withdrawn From the Study Due to Inadequate Efficacy

Safety Population included all participants who received any dose of study drug.

Posted

Count of Participants

Participants

Baseline up to Week 28 (end of study)

ID	Title	Description
OG000	Cohort A: Roxadustat Tiered, Weight Based Dosing TIW	Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
OG001	Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW	Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.

Secondary

Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24

Dose changes include dose reductions, dose increases, and dose holds.

Safety Population included all participants who received any dose of study drug. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint.

Posted

Count of Participants

Participants

Weeks 1-4, 5-12, and 13-16 (all cohorts) and Weeks 17-24 (24-week treatment cohorts only)

ID	Title	Description
OG000	Cohort A: Roxadustat Tiered, Weight Based Dosing TIW	Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
OG001	Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW	Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.

Secondary

Weekly Total Dose and Cumulative Total Dose (mg/kg) When First Achieving Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)

Posted

Mean

Standard Deviation

mg/kg

Cohorts A and B: Weekly through Week 16 (end of treatment); Cohorts C-F: Weekly through Week 24 (end of treatment)

ID	Title	Description
OG000	Cohort A: Roxadustat Tiered, Weight Based Dosing TIW	Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
OG001	Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW	Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.

Secondary

Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)

Safety Population included all participants who received any dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified timepoint.

Posted

Mean

Standard Deviation

mg/kg

Cohorts A and B: Weekly through Week 16 (end of treatment); Cohorts C-F: Weekly through Week 24 (end of treatment)

ID	Title	Description
OG000	Cohort A: Roxadustat Tiered, Weight Based Dosing TIW	Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
OG001	Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW	Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.

Secondary

Change From Baseline in Hb Stratified by Baseline Ferritin >100 Nanograms/Milliliter (ng/mL) and Transferrin Saturation >20% at Week 16 and Week 24

Baseline was defined as the mean of the last 3 available values predose.

Posted

Mean

Standard Deviation

g/dL

Baseline, Weeks 16 (Cohorts A and B End of Treatment) and Week 24 (Cohorts C-F End of Treatment)

ID	Title	Description
OG000	Cohort A: Roxadustat Tiered, Weight Based Dosing TIW	Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
OG001	Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW	Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort A: Roxadustat Tiered, Weight Based Dosing TIW	Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.	3	24	15	24
EG001	Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW	Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response.	4	24	15	24
EG002	Cohort C: Roxadustat at 50 mg TIW	Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.	4	24	10	24
EG003	Cohort D: Roxadustat at 100 mg TIW	Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.	4	24	10	24
EG004	Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW	Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response.	10	24	11	24
EG005	Cohort F: Roxadustat at 70 mg BIW Then QW	Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency was reduced from BIW to QW.	10	25	10	25

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac Failure Congestive	Cardiac disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0021 affected24 at risk EG0031 affected24 at risk EG0040 affected24 at risk EG0053 affected25 at risk
Cardio-Respiratory Arrest	Cardiac disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0021 affected24 at risk EG003
Acute Myocardial Infarction	Cardiac disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Atrial Fibrillation	Cardiac disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Myocardial Infarction	Cardiac disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Renal Failure Acute	Renal and urinary disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0011 affected24 at risk EG0021 affected24 at risk EG003
Renal Failure Chronic	Renal and urinary disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Renal Impairment	Renal and urinary disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Abdominal Pain Lower	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0021 affected24 at risk EG003
Diabetic Gastroparesis	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0021 affected24 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Pancreatitis Acute	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Cellulitis	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Abscess	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Bronchopneumonia	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0001 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Pneumonia	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0011 affected24 at risk EG0020 affected24 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0021 affected24 at risk EG003
Diabetic Ketoacidosis	Metabolism and nutrition disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Hyperglycaemic Hyperosmolar Nonketotic Syndrome	Metabolism and nutrition disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Brain Stem Infarction	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Cerebellar Infarction	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Subarachnoid Haemorrhage	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0011 affected24 at risk EG0020 affected24 at risk EG003
Syncope	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0011 affected24 at risk EG0020 affected24 at risk EG003
Foreign Body	Injury, poisoning and procedural complications	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0011 affected24 at risk EG0020 affected24 at risk EG003
Spinal Fracture	Injury, poisoning and procedural complications	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Toxicity To Various Agents	Injury, poisoning and procedural complications	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0011 affected24 at risk EG0020 affected24 at risk EG003
Death	General disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0011 affected24 at risk EG0020 affected24 at risk EG003
Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Hypotension	Vascular disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Urinary Tract Infection	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0000 affected24 at risk EG0014 affected24 at risk EG0022 affected24 at risk EG0031 affected24 at risk EG0044 affected24 at risk EG0053 affected25 at risk
Nasopharyngitis	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0002 affected24 at risk EG0012 affected24 at risk EG0022 affected24 at risk EG003
Sinusitis	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0002 affected24 at risk EG0013 affected24 at risk EG0022 affected24 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0004 affected24 at risk EG0011 affected24 at risk EG0021 affected24 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0003 affected24 at risk EG0014 affected24 at risk EG0022 affected24 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0002 affected24 at risk EG0012 affected24 at risk EG0021 affected24 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0003 affected24 at risk EG0011 affected24 at risk EG0020 affected24 at risk EG003
Oedema Peripheral	General disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected24 at risk EG0015 affected24 at risk EG0024 affected24 at risk EG003
Dizziness	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0002 affected24 at risk EG0011 affected24 at risk EG0023 affected24 at risk EG003
Headache	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0003 affected24 at risk EG0011 affected24 at risk EG0021 affected24 at risk EG003
Hypertension	Vascular disorders	MedDRA (15.1)	Systematic Assessment	EG0004 affected24 at risk EG0011 affected24 at risk EG0021 affected24 at risk EG003

Facility	Status	City	State	ZIP	Country	Contacts
		Mobile	Alabama		United States

ID	Term
D051436	Renal Insufficiency, Chronic
D000740	Anemia

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases