Trial Outcomes & Findings for Phase 2 Study of Roxadustat in Participants With Anemia and Chronic Kidney Disease Not Requiring Dialysis (NCT NCT00761657)

Last Updated: 2021-11-19

Results Overview

An adverse event (AE) was any untoward medical event in a participant who received study drug whether or not the event is considered drug related. TEAEs defined as an AE beginning after first dose of study drug until 28 days after last dose of study drug or existing AEs that worsened after first dose of study drug until the participant's last study visit. Severe AEs defined as incapacitating, inability to perform usual activities. Drug-related TEAEs defined as TEAEs with possible, probable, or definite relationship to study drug. Serious AE criteria included death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed here. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

117 participants

Primary outcome timeframe

Baseline up to Week 16 (End of Study (EoS])

Results posted on

2021-11-19

Participant Flow

On 08 May 2007, the Food and Drug Administration (FDA) placed a clinical hold on the study. The clinical hold resulted in early termination of Part 1 of the study. On 24 March 2008, the FDA lifted the clinical hold and Part 2 of this study started.

Participant milestones

Participant milestones
Measure	Roxadustat 0.7 Milligrams/Kilograms (mg/kg) BIW Participants received roxadustat 0.7 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 0.7 mg/kg TIW Participants received roxadustat 0.7 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Roxadustat 1.0 mg/kg BIW Participants received roxadustat 1.0 mg/kg BIW orally with doses administered at least 72 hours apart for 29 days.	Roxadustat 1.0 mg/kg TIW Participants received roxadustat 1.0 mg/kg TIW orally with doses administered at least 48 hours apart for 26 days.	Roxadustat 1.5 mg/kg BIW Participants received roxadustat 1.5 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 1.5 mg/kg TIW Participants received roxadustat 1.5 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Roxadustat 2.0 mg/kg BIW Participants received roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 2.0 mg/kg TIW Participants received roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Placebo Participants received placebo orally, matching to the roxadustat dose, number of days per week, and duration.
Part 1 (up to Day 57) STARTED	0	0	12	10	0	0	1	2	10
Part 1 (up to Day 57) Safety Population	0	0	12	9	0	0	1	2	10
Part 1 (up to Day 57) Efficacy Evaluable (EE) Population	0	0	5	5	0	0	0	1	6
Part 1 (up to Day 57) Pharmacokinetic (PK) Population	0	0	5	3	0	0	1	2	0
Part 1 (up to Day 57) COMPLETED	0	0	8	4	0	0	0	1	9
Part 1 (up to Day 57) NOT COMPLETED	0	0	4	6	0	0	1	1	1
Part 2 (up to Day 114) STARTED	10	13	0	0	10	11	10	10	18
Part 2 (up to Day 114) Safety Population	10	13	0	0	10	11	10	10	18
Part 2 (up to Day 114) EE Population	10	12	0	0	10	11	10	10	11
Part 2 (up to Day 114) PK Population	10	13	0	0	10	11	10	10	0
Part 2 (up to Day 114) COMPLETED	10	13	0	0	10	11	10	10	17
Part 2 (up to Day 114) NOT COMPLETED	0	0	0	0	0	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Roxadustat 1.0 mg/kg BIW Participants received roxadustat 1.0 mg/kg BIW orally with doses administered at least 72 hours apart for 29 days.	Roxadustat 1.0 mg/kg TIW Participants received roxadustat 1.0 mg/kg TIW orally with doses administered at least 48 hours apart for 26 days.	Roxadustat 2.0 mg/kg BIW Participants received roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 2.0 mg/kg TIW Participants received roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Placebo Participants received placebo orally, matching to the roxadustat dose, number of days per week, and duration.
Part 1 (up to Day 57) Adverse Event	0	1	0	0	0
Part 1 (up to Day 57) Withdrawal by Subject	1	1	0	0	0
Part 1 (up to Day 57) Sponsor Decision	3	4	1	1	1
Part 2 (up to Day 114) Adverse Event	0	0	0	0	1

Baseline Characteristics

Phase 2 Study of Roxadustat in Participants With Anemia and Chronic Kidney Disease Not Requiring Dialysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Roxadustat 0.7 mg/kg BIW n=10 Participants Participants received roxadustat 0.7 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 0.7 mg/kg TIW n=13 Participants Participants received roxadustat 0.7 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Roxadustat 1.0 mg/kg BIW n=12 Participants Participants received roxadustat 1.0 mg/kg BIW orally with doses administered at least 72 hours apart for 29 days.	Roxadustat 1.0 mg/kg TIW n=9 Participants Participants received roxadustat 1.0 mg/kg TIW orally with doses administered at least 48 hours apart for 26 days.	Roxadustat 1.5 mg/kg BIW n=10 Participants Participants received roxadustat 1.5 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 1.5 mg/kg TIW n=11 Participants Participants received roxadustat 1.5 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Roxadustat 2.0 mg/kg BIW n=11 Participants Participants received roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 2.0 mg/kg TIW n=12 Participants Participants received roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Placebo n=28 Participants Participants received placebo orally, matching to the roxadustat dose, number of days per week, and duration.	Total n=116 Participants Total of all reporting groups
Age, Continuous	64.6 years STANDARD_DEVIATION 4.9 • n=5 Participants	60.6 years STANDARD_DEVIATION 9.2 • n=7 Participants	69.5 years STANDARD_DEVIATION 7.7 • n=5 Participants	67.0 years STANDARD_DEVIATION 8.4 • n=4 Participants	63.8 years STANDARD_DEVIATION 8.8 • n=21 Participants	63.5 years STANDARD_DEVIATION 6.4 • n=10 Participants	64.3 years STANDARD_DEVIATION 9.0 • n=115 Participants	66.8 years STANDARD_DEVIATION 7.8 • n=24 Participants	68.6 years STANDARD_DEVIATION 6.2 • n=42 Participants	65.8 years STANDARD_DEVIATION 7.8 • n=42 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants	10 Participants n=10 Participants	8 Participants n=115 Participants	9 Participants n=24 Participants	12 Participants n=42 Participants	67 Participants n=42 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	4 Participants n=21 Participants	1 Participants n=10 Participants	3 Participants n=115 Participants	3 Participants n=24 Participants	16 Participants n=42 Participants	49 Participants n=42 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 16 (End of Study (EoS])

Population: Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	Roxadustat 0.7 mg/kg BIW n=10 Participants Participants received roxadustat 0.7 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 0.7 mg/kg TIW n=13 Participants Participants received roxadustat 0.7 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Roxadustat 1.0 mg/kg BIW n=12 Participants Participants received roxadustat 1.0 mg/kg BIW orally with doses administered at least 72 hours apart for 29 days.	Roxadustat 1.0 mg/kg TIW n=9 Participants Participants received roxadustat 1.0 mg/kg TIW orally with doses administered at least 48 hours apart for 26 days.	Roxadustat 1.5 mg/kg BIW n=10 Participants Participants received roxadustat 1.5 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 1.5 mg/kg TIW n=11 Participants Participants received roxadustat 1.5 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Roxadustat 2.0 mg/kg BIW n=11 Participants Participants received roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 2.0 mg/kg TIW n=12 Participants Participants received roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Placebo n=28 Participants Participants received placebo orally, matching to the roxadustat dose, number of days per week, and duration.
Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) Any TEAEs	3 Participants	9 Participants	7 Participants	5 Participants	9 Participants	7 Participants	7 Participants	5 Participants	13 Participants
Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) Serious TEAEs	0 Participants	4 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) Drug-Related TEAEs	1 Participants	2 Participants	2 Participants	1 Participants	3 Participants	3 Participants	3 Participants	1 Participants	3 Participants
Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) Severe TEAEs	0 Participants	3 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) TEAEs Leading to Treatment Discontinuation	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Baseline, End of Treatment (EoT) (Day 26 for TIW Dosing or Day 29 for BIW Dosing)

Population: Part 1 and Part 2 EE Population: Participants who were anemic at baseline (Hb ≤11.0 g/dL and were in study treatment for at least 2.5 weeks with corresponding Hb values. Last-observation-carried-forward (LOCF) method was used to impute missing values.

Mean Hb change from baseline was analyzed by treatment group and study visit. Baseline was defined as the mean of last 3 available values prior to the first dose.

Outcome measures

Outcome measures
Measure	Roxadustat 0.7 mg/kg BIW n=10 Participants Participants received roxadustat 0.7 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 0.7 mg/kg TIW n=12 Participants Participants received roxadustat 0.7 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Roxadustat 1.0 mg/kg BIW n=5 Participants Participants received roxadustat 1.0 mg/kg BIW orally with doses administered at least 72 hours apart for 29 days.	Roxadustat 1.0 mg/kg TIW n=5 Participants Participants received roxadustat 1.0 mg/kg TIW orally with doses administered at least 48 hours apart for 26 days.	Roxadustat 1.5 mg/kg BIW n=10 Participants Participants received roxadustat 1.5 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 1.5 mg/kg TIW n=11 Participants Participants received roxadustat 1.5 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Roxadustat 2.0 mg/kg BIW n=9 Participants Participants received roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 2.0 mg/kg TIW n=11 Participants Participants received roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Placebo n=23 Participants Participants received placebo orally, matching to the roxadustat dose, number of days per week, and duration.
Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment) Change at Day 26-29	0.25 g/dL Standard Deviation 0.849	0.60 g/dL Standard Deviation 0.756	0.44 g/dL Standard Deviation 0.781	0.21 g/dL Standard Deviation 1.016	1.22 g/dL Standard Deviation 1.112	1.65 g/dL Standard Deviation 1.033	1.35 g/dL Standard Deviation 0.577	1.75 g/dL Standard Deviation 1.200	-0.05 g/dL Standard Deviation 0.500
Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment) Baseline	10.32 g/dL Standard Deviation 0.678	10.03 g/dL Standard Deviation 0.709	9.18 g/dL Standard Deviation 0.600	10.35 g/dL Standard Deviation 0.849	10.28 g/dL Standard Deviation 0.551	10.08 g/dL Standard Deviation 0.650	9.97 g/dL Standard Deviation 0.430	9.93 g/dL Standard Deviation 0.806	10.10 g/dL Standard Deviation 0.616

PRIMARY outcome

Timeframe: Baseline, Week 8 (2 Weeks of Follow Up)

Mean Hb change from baseline was analyzed by treatment group and study visit. Baseline is defined as the mean of last 3 available values prior to the first dose.

Outcome measures

Outcome measures
Measure	Roxadustat 0.7 mg/kg BIW n=10 Participants Participants received roxadustat 0.7 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 0.7 mg/kg TIW n=12 Participants Participants received roxadustat 0.7 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Roxadustat 1.0 mg/kg BIW n=5 Participants Participants received roxadustat 1.0 mg/kg BIW orally with doses administered at least 72 hours apart for 29 days.	Roxadustat 1.0 mg/kg TIW n=5 Participants Participants received roxadustat 1.0 mg/kg TIW orally with doses administered at least 48 hours apart for 26 days.	Roxadustat 1.5 mg/kg BIW n=10 Participants Participants received roxadustat 1.5 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 1.5 mg/kg TIW n=11 Participants Participants received roxadustat 1.5 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Roxadustat 2.0 mg/kg BIW n=9 Participants Participants received roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 2.0 mg/kg TIW n=11 Participants Participants received roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Placebo n=23 Participants Participants received placebo orally, matching to the roxadustat dose, number of days per week, and duration.
Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up) Baseline	10.32 g/dL Standard Deviation 0.678	10.03 g/dL Standard Deviation 0.709	9.18 g/dL Standard Deviation 0.600	10.35 g/dL Standard Deviation 0.849	10.28 g/dL Standard Deviation 0.551	10.08 g/dL Standard Deviation 0.650	9.97 g/dL Standard Deviation 0.430	9.93 g/dL Standard Deviation 0.806	10.10 g/dL Standard Deviation 0.616
Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up) Change at Week 8	0.59 g/dL Standard Deviation 0.808	0.24 g/dL Standard Deviation 0.846	0.50 g/dL Standard Deviation 0.356	0.05 g/dL Standard Deviation 1.435	0.79 g/dL Standard Deviation 0.916	1.31 g/dL Standard Deviation 0.743	1.21 g/dL Standard Deviation 0.656	1.52 g/dL Standard Deviation 0.815	0.04 g/dL Standard Deviation 0.684

SECONDARY outcome

Timeframe: Baseline up to Day 26-29 (EoT), up to Week 8 (2 weeks of follow up), and up to Week 16 (EoS, 4 weeks of follow up)

Population: Part 1 and Part 2 EE Population: Participants who were anemic at baseline (Hb ≤11.0 g/dL) and were in study treatment for at least 2.5 weeks with corresponding Hb values.

Hb response defined as an increase in Hb from baseline by ≥1.0 g/dL (not due to red blood cell transfusion or IV iron supplementation during treatment). The baseline for Hb was defined as the mean of the last 3 available Hb values obtained prior to the first dose.

Outcome measures

Outcome measures
Measure	Roxadustat 0.7 mg/kg BIW n=10 Participants Participants received roxadustat 0.7 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 0.7 mg/kg TIW n=12 Participants Participants received roxadustat 0.7 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Roxadustat 1.0 mg/kg BIW n=5 Participants Participants received roxadustat 1.0 mg/kg BIW orally with doses administered at least 72 hours apart for 29 days.	Roxadustat 1.0 mg/kg TIW n=5 Participants Participants received roxadustat 1.0 mg/kg TIW orally with doses administered at least 48 hours apart for 26 days.	Roxadustat 1.5 mg/kg BIW n=10 Participants Participants received roxadustat 1.5 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 1.5 mg/kg TIW n=11 Participants Participants received roxadustat 1.5 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Roxadustat 2.0 mg/kg BIW n=9 Participants Participants received roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 2.0 mg/kg TIW n=11 Participants Participants received roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Placebo n=23 Participants Participants received placebo orally, matching to the roxadustat dose, number of days per week, and duration.
Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) Day 26-29	1 Participants	6 Participants	1 Participants	1 Participants	8 Participants	10 Participants	7 Participants	9 Participants	3 Participants
Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) Week 8	5 Participants	7 Participants	3 Participants	2 Participants	8 Participants	10 Participants	9 Participants	11 Participants	6 Participants
Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) Week 16	7 Participants	7 Participants	3 Participants	2 Participants	9 Participants	10 Participants	9 Participants	11 Participants	8 Participants

SECONDARY outcome

Timeframe: Predose on Days 3 (TIW dose groups) or 4 (BIW dose groups), 8, 15, 22, and 26 (TIW dose groups) or 29 (BIW dose groups)

Population: Part 2 PK Population: Participants who received roxadustat and had sufficient plasma data to allow calculation of PK parameters. Participants in the roxadustat groups were evaluated. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified timepoint.

Outcome measures

Outcome measures
Measure	Roxadustat 0.7 mg/kg BIW n=10 Participants Participants received roxadustat 0.7 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 0.7 mg/kg TIW n=13 Participants Participants received roxadustat 0.7 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Roxadustat 1.0 mg/kg BIW n=10 Participants Participants received roxadustat 1.0 mg/kg BIW orally with doses administered at least 72 hours apart for 29 days.	Roxadustat 1.0 mg/kg TIW n=11 Participants Participants received roxadustat 1.0 mg/kg TIW orally with doses administered at least 48 hours apart for 26 days.	Roxadustat 1.5 mg/kg BIW n=9 Participants Participants received roxadustat 1.5 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 1.5 mg/kg TIW n=10 Participants Participants received roxadustat 1.5 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Roxadustat 2.0 mg/kg BIW Participants received roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 2.0 mg/kg TIW Participants received roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Placebo Participants received placebo orally, matching to the roxadustat dose, number of days per week, and duration.
Plasma Roxadustat Concentration (Part 2) Day 3	—	394.800 nanograms (ng)/milliliter (mL) Standard Deviation 723.156	—	260.027 nanograms (ng)/milliliter (mL) Standard Deviation 133.524	—	422.700 nanograms (ng)/milliliter (mL) Standard Deviation 148.529	—	—	—
Plasma Roxadustat Concentration (Part 2) Day 4	28.596 nanograms (ng)/milliliter (mL) Standard Deviation 19.737	—	168.310 nanograms (ng)/milliliter (mL) Standard Deviation 174.426	—	283.067 nanograms (ng)/milliliter (mL) Standard Deviation 376.601	—	—	—	—
Plasma Roxadustat Concentration (Part 2) Day 8	19.884 nanograms (ng)/milliliter (mL) Standard Deviation 18.858	203.535 nanograms (ng)/milliliter (mL) Standard Deviation 343.167	125.185 nanograms (ng)/milliliter (mL) Standard Deviation 223.124	168.955 nanograms (ng)/milliliter (mL) Standard Deviation 147.019	291.856 nanograms (ng)/milliliter (mL) Standard Deviation 376.910	297.500 nanograms (ng)/milliliter (mL) Standard Deviation 393.134	—	—	—
Plasma Roxadustat Concentration (Part 2) Day 15	22.997 nanograms (ng)/milliliter (mL) Standard Deviation 18.442	195.483 nanograms (ng)/milliliter (mL) Standard Deviation 369.794	134.116 nanograms (ng)/milliliter (mL) Standard Deviation 269.890	247.945 nanograms (ng)/milliliter (mL) Standard Deviation 204.624	358.400 nanograms (ng)/milliliter (mL) Standard Deviation 491.898	175.570 nanograms (ng)/milliliter (mL) Standard Deviation 144.779	—	—	—
Plasma Roxadustat Concentration (Part 2) Day 22	36.432 nanograms (ng)/milliliter (mL) Standard Deviation 33.587	153.903 nanograms (ng)/milliliter (mL) Standard Deviation 173.388	147.323 nanograms (ng)/milliliter (mL) Standard Deviation 235.302	163.100 nanograms (ng)/milliliter (mL) Standard Deviation 167.695	171.833 nanograms (ng)/milliliter (mL) Standard Deviation 138.575	239.600 nanograms (ng)/milliliter (mL) Standard Deviation 324.307	—	—	—
Plasma Roxadustat Concentration (Part 2) Day 26	—	331.640 nanograms (ng)/milliliter (mL) Standard Deviation 435.773	—	223.140 nanograms (ng)/milliliter (mL) Standard Deviation 140.340	—	508.889 nanograms (ng)/milliliter (mL) Standard Deviation 295.228	—	—	—
Plasma Roxadustat Concentration (Part 2) Day 29	14.332 nanograms (ng)/milliliter (mL) Standard Deviation 9.935	—	150.599 nanograms (ng)/milliliter (mL) Standard Deviation 233.871	—	193.622 nanograms (ng)/milliliter (mL) Standard Deviation 279.533	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1), 1, 2, 3, 4, 6, 8, 12, 18, 24, 48, and 72 hours on Day 26 (TIW Dosing) or Day 29 (BIW Dosing)

Population: Part 1 Safety Population: Participants who received at least 1 dose of study drug. Participants with missing erythropoietin values at any timepoint were excluded from analysis. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint.

Baseline is defined as the last value obtained prior to the first dose.

Outcome measures

Outcome measures
Measure	Roxadustat 0.7 mg/kg BIW n=5 Participants Participants received roxadustat 0.7 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 0.7 mg/kg TIW n=3 Participants Participants received roxadustat 0.7 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Roxadustat 1.0 mg/kg BIW n=1 Participants Participants received roxadustat 1.0 mg/kg BIW orally with doses administered at least 72 hours apart for 29 days.	Roxadustat 1.0 mg/kg TIW n=2 Participants Participants received roxadustat 1.0 mg/kg TIW orally with doses administered at least 48 hours apart for 26 days.	Roxadustat 1.5 mg/kg BIW n=6 Participants Participants received roxadustat 1.5 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 1.5 mg/kg TIW Participants received roxadustat 1.5 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Roxadustat 2.0 mg/kg BIW Participants received roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 2.0 mg/kg TIW Participants received roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Placebo Participants received placebo orally, matching to the roxadustat dose, number of days per week, and duration.
Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 Day 1, Baseline	13.46 milli-international units (mIU)/mL Standard Deviation 5.69	13.30 milli-international units (mIU)/mL Standard Deviation 6.59	9.00 milli-international units (mIU)/mL Standard Deviation NA NA=Standard Deviation cannot be calculated with N of 1.	8.50 milli-international units (mIU)/mL Standard Deviation 3.96	13.75 milli-international units (mIU)/mL Standard Deviation 4.53	—	—	—	—
Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 Change at Day 29, 72 Hour	-2.93 milli-international units (mIU)/mL Standard Deviation 3.91	—	—	—	-1.63 milli-international units (mIU)/mL Standard Deviation 4.71	—	—	—	—
Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 Change at Day 26, 1 Hour	—	-1.50 milli-international units (mIU)/mL Standard Deviation 1.41	—	0.00 milli-international units (mIU)/mL Standard Deviation NA NA=Standard Deviation cannot be calculated with N of 1.	0.17 milli-international units (mIU)/mL Standard Deviation 0.21	—	—	—	—
Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 Change at Day 26, 2 Hour	—	-0.85 milli-international units (mIU)/mL Standard Deviation 1.91	—	-0.60 milli-international units (mIU)/mL Standard Deviation NA NA=Standard Deviation cannot be calculated with N of 1.	0.67 milli-international units (mIU)/mL Standard Deviation 1.47	—	—	—	—
Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 Change at Day 26, 3 Hour	—	-0.95 milli-international units (mIU)/mL Standard Deviation 1.34	—	2.30 milli-international units (mIU)/mL Standard Deviation NA NA=Standard Deviation cannot be calculated with N of 1.	-1.27 milli-international units (mIU)/mL Standard Deviation 3.15	—	—	—	—
Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 Change at Day 26, 4 Hour	—	-0.45 milli-international units (mIU)/mL Standard Deviation 0.07	—	29.70 milli-international units (mIU)/mL Standard Deviation NA NA=Standard Deviation cannot be calculated with N of 1.	0.50 milli-international units (mIU)/mL Standard Deviation 4.24	—	—	—	—
Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 Change at Day 26, 6 Hour	—	8.05 milli-international units (mIU)/mL Standard Deviation 11.81	—	132.80 milli-international units (mIU)/mL Standard Deviation NA NA=Standard Deviation cannot be calculated with N of 1.	0.33 milli-international units (mIU)/mL Standard Deviation 3.80	—	—	—	—
Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 Change at Day 26, 8 Hour	—	57.95 milli-international units (mIU)/mL Standard Deviation 63.29	—	462.00 milli-international units (mIU)/mL Standard Deviation NA NA=Standard Deviation cannot be calculated with N of 1.	0.20 milli-international units (mIU)/mL Standard Deviation 1.18	—	—	—	—
Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 Change at Day 26, 12 Hour	—	81.80 milli-international units (mIU)/mL Standard Deviation 81.03	—	492.00 milli-international units (mIU)/mL Standard Deviation NA NA=Standard Deviation cannot be calculated with N of 1.	-1.30 milli-international units (mIU)/mL Standard Deviation 1.71	—	—	—	—
Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 Change at Day 26, 18 Hour	—	37.30 milli-international units (mIU)/mL Standard Deviation 13.01	—	176.90 milli-international units (mIU)/mL Standard Deviation NA NA=Standard Deviation cannot be calculated with N of 1.	0.87 milli-international units (mIU)/mL Standard Deviation 1.07	—	—	—	—
Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 Change at Day 26, 24 Hour	—	22.35 milli-international units (mIU)/mL Standard Deviation 19.73	—	33.90 milli-international units (mIU)/mL Standard Deviation NA NA=Standard Deviation cannot be calculated with N of 1.	2.60 milli-international units (mIU)/mL Standard Deviation 5.46	—	—	—	—
Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 Change at Day 26, 48 Hour	—	0.55 milli-international units (mIU)/mL Standard Deviation 10.39	—	-0.50 milli-international units (mIU)/mL Standard Deviation NA NA=Standard Deviation cannot be calculated with N of 1.	-7.50 milli-international units (mIU)/mL Standard Deviation 2.40	—	—	—	—
Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 Change at Day 26, 72 Hour	—	-2.85 milli-international units (mIU)/mL Standard Deviation 5.02	—	-1.50 milli-international units (mIU)/mL Standard Deviation NA NA=Standard Deviation cannot be calculated with N of 1.	-0.60 milli-international units (mIU)/mL Standard Deviation 1.27	—	—	—	—
Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 Change at Day 29, 1 Hour	-1.08 milli-international units (mIU)/mL Standard Deviation 1.22	—	—	—	-1.57 milli-international units (mIU)/mL Standard Deviation 1.14	—	—	—	—
Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 Change at Day 29, 2 Hour	-1.27 milli-international units (mIU)/mL Standard Deviation 2.23	—	—	—	-2.73 milli-international units (mIU)/mL Standard Deviation 1.85	—	—	—	—
Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 Change at Day 29, 3 Hour	-0.55 milli-international units (mIU)/mL Standard Deviation 1.13	—	—	—	-3.70 milli-international units (mIU)/mL Standard Deviation 2.14	—	—	—	—
Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 Change at Day 29, 4 Hour	12.03 milli-international units (mIU)/mL Standard Deviation 10.12	—	—	—	-4.90 milli-international units (mIU)/mL Standard Deviation 1.95	—	—	—	—
Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 Change at Day 29, 6 Hour	66.85 milli-international units (mIU)/mL Standard Deviation 43.07	—	—	—	-4.17 milli-international units (mIU)/mL Standard Deviation 1.27	—	—	—	—
Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 Change at Day 29, 8 Hour	135.08 milli-international units (mIU)/mL Standard Deviation 83.95	—	—	—	-2.97 milli-international units (mIU)/mL Standard Deviation 2.20	—	—	—	—
Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 Change at Day 29, 12 Hour	77.35 milli-international units (mIU)/mL Standard Deviation 43.80	—	—	—	-2.07 milli-international units (mIU)/mL Standard Deviation 1.08	—	—	—	—
Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 Change at Day 29, 18 Hour	43.80 milli-international units (mIU)/mL Standard Deviation 13.41	—	—	—	-0.20 milli-international units (mIU)/mL Standard Deviation 1.77	—	—	—	—
Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 Change at Day 29, 24 Hour	10.18 milli-international units (mIU)/mL Standard Deviation 3.16	—	—	—	-3.07 milli-international units (mIU)/mL Standard Deviation 0.96	—	—	—	—
Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 Change at Day 29, 48 Hour	-5.17 milli-international units (mIU)/mL Standard Deviation 4.70	—	—	—	-4.87 milli-international units (mIU)/mL Standard Deviation 2.24	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 4, 8, 12, and 24 hours on Day 1

Population: Part 2 PK Population: Participants who received roxadustat and had sufficient plasma data to allow calculation of PK parameters. Participants with missing erythropoietin values at any timepoint were excluded from analysis.

Baseline is defined as the last value obtained prior to the first dose.

Outcome measures

Outcome measures
Measure	Roxadustat 0.7 mg/kg BIW Participants received roxadustat 0.7 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 0.7 mg/kg TIW n=2 Participants Participants received roxadustat 0.7 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Roxadustat 1.0 mg/kg BIW n=2 Participants Participants received roxadustat 1.0 mg/kg BIW orally with doses administered at least 72 hours apart for 29 days.	Roxadustat 1.0 mg/kg TIW Participants received roxadustat 1.0 mg/kg TIW orally with doses administered at least 48 hours apart for 26 days.	Roxadustat 1.5 mg/kg BIW n=2 Participants Participants received roxadustat 1.5 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 1.5 mg/kg TIW Participants received roxadustat 1.5 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Roxadustat 2.0 mg/kg BIW Participants received roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 2.0 mg/kg TIW Participants received roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Placebo Participants received placebo orally, matching to the roxadustat dose, number of days per week, and duration.
Change From Baseline in Plasma Erythropoietin in Part 2 Participants at 4, 8, 12, and 24 Hours on Day 1 Baseline	—	8.30 mIU/mL Standard Deviation 2.26	9.55 mIU/mL Standard Deviation 3.32	—	10.45 mIU/mL Standard Deviation 4.31	—	—	—	—
Change From Baseline in Plasma Erythropoietin in Part 2 Participants at 4, 8, 12, and 24 Hours on Day 1 Change at 12 Hour	—	66.25 mIU/mL Standard Deviation 90.16	147.15 mIU/mL Standard Deviation 128.91	—	201.10 mIU/mL Standard Deviation 240.42	—	—	—	—
Change From Baseline in Plasma Erythropoietin in Part 2 Participants at 4, 8, 12, and 24 Hours on Day 1 Change at 4 Hour	—	2.80 mIU/mL Standard Deviation 3.96	2.10 mIU/mL Standard Deviation 3.54	—	1.00 mIU/mL Standard Deviation 2.97	—	—	—	—
Change From Baseline in Plasma Erythropoietin in Part 2 Participants at 4, 8, 12, and 24 Hours on Day 1 Change at 8 Hour	—	66.70 mIU/mL Standard Deviation 90.23	100.40 mIU/mL Standard Deviation 92.77	—	42.05 mIU/mL Standard Deviation 36.98	—	—	—	—
Change From Baseline in Plasma Erythropoietin in Part 2 Participants at 4, 8, 12, and 24 Hours on Day 1 Change at 24 Hour	—	10.05 mIU/mL Standard Deviation 8.56	107.65 mIU/mL Standard Deviation 53.25	—	461.05 mIU/mL Standard Deviation 589.80	—	—	—	—

Adverse Events

Roxadustat 0.7 mg/kg BIW

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Roxadustat 0.7 mg/kg TIW

Serious events: 4 serious events

Other events: 9 other events

Deaths: 0 deaths

Roxadustat 1.0 mg/kg BIW

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Roxadustat 1.0 mg/kg TIW

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Roxadustat 1.5 mg/kg BIW

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Roxadustat 1.5 mg/kg TIW

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Roxadustat 2.0 mg/kg BIW

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Roxadustat 2.0 mg/kg TIW

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Roxadustat 0.7 mg/kg BIW n=10 participants at risk Participants received roxadustat 0.7 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 0.7 mg/kg TIW n=13 participants at risk Participants received roxadustat 0.7 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Roxadustat 1.0 mg/kg BIW n=12 participants at risk Participants received roxadustat 1.0 mg/kg BIW orally with doses administered at least 72 hours apart for 29 days.	Roxadustat 1.0 mg/kg TIW n=9 participants at risk Participants received roxadustat 1.0 mg/kg TIW orally with doses administered at least 48 hours apart for 26 days.	Roxadustat 1.5 mg/kg BIW n=10 participants at risk Participants received roxadustat 1.5 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 1.5 mg/kg TIW n=11 participants at risk Participants received roxadustat 1.5 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Roxadustat 2.0 mg/kg BIW n=11 participants at risk Participants received roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 2.0 mg/kg TIW n=12 participants at risk Participants received roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Placebo n=28 participants at risk Participants received placebo orally, matching to the roxadustat dose, number of days per week, and duration.
Injury, poisoning and procedural complications Arteriovenous fistula site	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.7% 1/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.7% 1/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Cardiac disorders Pericarditis	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	3.6% 1/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
General disorders Non-cardiac chest pain	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.7% 1/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Renal and urinary disorders Renal failure acute	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	3.6% 1/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.7% 1/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.

Other adverse events

Other adverse events
Measure	Roxadustat 0.7 mg/kg BIW n=10 participants at risk Participants received roxadustat 0.7 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 0.7 mg/kg TIW n=13 participants at risk Participants received roxadustat 0.7 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Roxadustat 1.0 mg/kg BIW n=12 participants at risk Participants received roxadustat 1.0 mg/kg BIW orally with doses administered at least 72 hours apart for 29 days.	Roxadustat 1.0 mg/kg TIW n=9 participants at risk Participants received roxadustat 1.0 mg/kg TIW orally with doses administered at least 48 hours apart for 26 days.	Roxadustat 1.5 mg/kg BIW n=10 participants at risk Participants received roxadustat 1.5 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 1.5 mg/kg TIW n=11 participants at risk Participants received roxadustat 1.5 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Roxadustat 2.0 mg/kg BIW n=11 participants at risk Participants received roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.	Roxadustat 2.0 mg/kg TIW n=12 participants at risk Participants received roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.	Placebo n=28 participants at risk Participants received placebo orally, matching to the roxadustat dose, number of days per week, and duration.
Gastrointestinal disorders Diarrhoea	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	23.1% 3/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	16.7% 2/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	11.1% 1/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	10.0% 1/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	9.1% 1/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.1% 2/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Gastrointestinal disorders Constipation	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	8.3% 1/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	3.6% 1/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	9.1% 1/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	8.3% 1/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	11.1% 1/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	3.6% 1/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.7% 1/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.7% 1/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Gastrointestinal disorders Ascites	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.7% 1/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Gastrointestinal disorders Dyspepsia	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	9.1% 1/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastritis	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	10.0% 1/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	11.1% 1/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Gastrointestinal disorders Lip swelling	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	9.1% 1/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Infections and infestations Urinary tract infection	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	11.1% 1/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	10.7% 3/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Infections and infestations Influenza	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	8.3% 1/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	3.6% 1/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Infections and infestations Bronchitis	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.7% 1/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Infections and infestations Cystitis	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	8.3% 1/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Infections and infestations Sinusitis	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.7% 1/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Infections and infestations Tooth abscess	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	9.1% 1/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Infections and infestations Tooth infection	10.0% 1/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	9.1% 1/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperkalaemia	10.0% 1/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	20.0% 2/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	9.1% 1/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	18.2% 2/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Acidosis	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	9.1% 1/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Anorexia	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	8.3% 1/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	10.0% 1/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	9.1% 1/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Gout	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	8.3% 1/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	8.3% 1/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypernatraemia	10.0% 1/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	8.3% 1/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	9.1% 1/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	9.1% 1/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.7% 1/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.7% 1/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	22.2% 2/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	10.0% 1/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	9.1% 1/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	3.6% 1/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	10.0% 1/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	3.6% 1/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.7% 1/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	11.1% 1/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	9.1% 1/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	9.1% 1/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
General disorders Fatigue	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	8.3% 1/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	11.1% 1/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	18.2% 2/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
General disorders Oedema peripheral	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.7% 1/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	8.3% 1/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	9.1% 1/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
General disorders Chills	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	8.3% 1/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
General disorders Oedema	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	9.1% 1/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
General disorders Pyrexia	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	8.3% 1/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Nervous system disorders Headache	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.7% 1/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	11.1% 1/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	30.0% 3/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	9.1% 1/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	3.6% 1/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Nervous system disorders Dizziness	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	8.3% 1/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	11.1% 1/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.1% 2/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Nervous system disorders Neuropathy peripheral	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	8.3% 1/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	10.0% 1/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	10.0% 1/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Increased tendency to bruise	10.0% 1/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Intertrigo	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	8.3% 1/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.7% 1/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	9.1% 1/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	8.3% 1/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	11.1% 1/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Cardiac disorders Sinus bradycardia	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.1% 2/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Cardiac disorders Bradycardia	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	10.0% 1/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Cardiac disorders Cardiac failure congestive	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.7% 1/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Cardiac disorders Ventricular extrasystoles	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	8.3% 1/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Excoriation	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	8.3% 1/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.7% 1/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Laceration	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	9.1% 1/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.7% 1/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	11.1% 1/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Investigations Alanine aminotransferase increased	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.7% 1/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Investigations Blood uric acid increased	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	9.1% 1/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Investigations Electrocardiogram poor R-wave progression	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	10.0% 1/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Investigations Electrocardiogram repolarisation abnormality	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	10.0% 1/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Investigations Hepatic enzyme increased	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	9.1% 1/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Immune system disorders Seasonal allergy	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	10.0% 1/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.1% 2/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Psychiatric disorders Insomnia	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.7% 1/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	9.1% 1/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	3.6% 1/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Psychiatric disorders Depression	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.7% 1/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Renal and urinary disorders Renal impairment	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	18.2% 2/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Renal and urinary disorders Micturition urgency	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	9.1% 1/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Allergic sinusitis	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	8.3% 1/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	8.3% 1/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	10.0% 1/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	10.0% 1/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Vascular disorders Hot flush	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	9.1% 1/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Vascular disorders Hypertension	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.7% 1/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Anaemia	10.0% 1/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.7% 1/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Endocrine disorders Hyperparathyroidism secondary	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	9.1% 1/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Endocrine disorders Hypothyroidism	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.7% 1/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Eye disorders Diabetic retinopathy	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.7% 1/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Eye disorders Eyelid oedema	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	8.3% 1/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Breast cyst	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	11.1% 1/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Prostatitis	0.00% 0/6 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/6 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/4 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	16.7% 1/6 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/4 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/1 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/3 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/3 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/16 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Ear and labyrinth disorders Ear pain	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	9.1% 1/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Hepatobiliary disorders Gallbladder polyp	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	9.1% 1/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign breast neoplasm	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	8.3% 1/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Surgical and medical procedures Nail operation	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.7% 1/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
General disorders Non-cardiac chest pain	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.7% 1/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	7.7% 1/13 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/9 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/10 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/11 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/12 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.	0.00% 0/28 • Baseline up to Week 16 (EoS) Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.

Additional Information

Clinical Trial Information Desk

FibroGen, Inc.

Phone: 415-978-1441

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER