Trial Outcomes & Findings for Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental Glomerulosclerosis (NCT NCT01613118)

Last Updated: 2025-05-15

Results Overview

Primary efficacy objective is to determine the change in UP/C in FSGS patients receiving RE-021 (Sparsentan) from baseline to 8 weeks over a range of dose levels compared to treatment with irbesartan as active control.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

109 participants

Primary outcome timeframe

8 weeks

Results posted on

2025-05-15

Participant Flow

For the Double-Blind (DB) period, patients were screened to confirm eligibility and underwent 2-wk washout period to discontinue ARBs or ACEIs if necessary. Subjects who completed DB period were evaluated to determine eligibility for the Open-Label Extension (OLE) period (up to 496 additional weeks), those treated with irbesartan were offered sparsentan in the OLE period. Dose changes were permitted during the OLE so all subjects enrolled in OLE are included in RE-021(Sparsentan)-OLE Period arm.

Participant milestones

Participant milestones
Measure	RE-021 (Sparsentan) 200 mg - Double-Blind Period RE-021 (Sparsentan) administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose was 200mg. Patients at \</= 50kg received half the RE-021 (Sparsentan) dose for the 8 week duration. RE-021 (Sparsentan): Oral, once-daily	RE-021 (Sparsentan) 400 mg - Double-Blind Period RE-021 (Sparsentan) administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose was 400mg. Patients at \</= 50kg received half the RE-021 (Sparsentan) dose for the 8 week duration. RE-021 (Sparsentan): Oral, once-daily	RE-021 (Sparsentan) 800 mg - Double-Blind Period RE-021 (Sparsentan) administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose was 800mg. Patients at \</= 50kg received half of the RE-021 (Sparsentan) dose for the 8 week duration. RE-021 (Sparsentan): Oral, once-daily	Irbesartan 300 mg - Double-Blind Period The control irbesartan was administered as a single oral dose of 150mg for the first week before being escalated to 300mg for the remaining 7 weeks. Patients at \</= 50kg received 150mg irbesartan for the 8 week duration. Irbesartan: Oral, once-daily	RE-021 (Sparsentan) - Open-Label Extension Period Includes all subjects who completed the Double-Blind period and enrolled in the Open-Label Extension period of the study. All subjects who completed the Double-Blind period were evaluated for response and safety at the Week 8 visit to determine eligibility for continued treatment on their assigned doses in an Open-Label Extension period for up to 496 additional weeks. Subjects treated with irbesartan during the Double-Blind period were offered sparsentan treatment at the dose they would have received according to the Double-Blind dose group in which they were enrolled. Sparsentan (RE-021): Oral, once-daily
Double-blind STARTED	13	26	34	36	0
Double-blind COMPLETED	13	23	32	35	0
Double-blind NOT COMPLETED	0	3	2	1	0
Open-label Extension STARTED	0	0	0	0	103
Open-label Extension Active at Study End	0	0	0	0	30
Open-label Extension COMPLETED	0	0	0	0	1
Open-label Extension NOT COMPLETED	0	0	0	0	102

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental Glomerulosclerosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RE-021 (Sparsentan) 200 mg - Double-Blind Period n=13 Participants RE-021 (Sparsentan) administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose was 200mg. Patients at \</= 50kg received half the RE-021 (Sparsentan) dose for the 8 week duration. RE-021 (Sparsentan): Oral, once-daily	RE-021 (Sparsentan) 400 mg - Double-Blind Period n=26 Participants RE-021 (Sparsentan) administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose was 400mg. Patients at \</= 50kg received half the RE-021 (Sparsentan) dose for the 8 week duration. RE-021 (Sparsentan): Oral, once-daily	RE-021 (Sparsentan) 800 mg - Double-Blind Period n=34 Participants RE-021 (Sparsentan) administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose was 800mg. Patients at \</= 50kg received half of the RE-021 (Sparsentan) dose for the 8 week duration. RE-021 (Sparsentan): Oral, once-daily	Irbesartan 300 mg - Double-Blind Period n=36 Participants The control irbesartan was administered as a single oral dose of 150mg for the first week before being escalated to 300mg for the remaining 7 weeks. Patients at \</= 50kg received 150mg irbesartan for the 8 week duration. Irbesartan: Oral, once-daily	Total n=109 Participants Total of all reporting groups
Age, Continuous	42.8 years STANDARD_DEVIATION 14.36 • n=5 Participants	38.3 years STANDARD_DEVIATION 16.78 • n=7 Participants	35.9 years STANDARD_DEVIATION 17.68 • n=5 Participants	34.1 years STANDARD_DEVIATION 15.96 • n=4 Participants	36.7 years STANDARD_DEVIATION 16.54 • n=21 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants	17 Participants n=4 Participants	49 Participants n=21 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	17 Participants n=7 Participants	17 Participants n=5 Participants	19 Participants n=4 Participants	60 Participants n=21 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Efficacy evaluable set

Outcome measures

Outcome measures
Measure	RE-021 (Sparsentan) 200, 400, 800 mg Pooled n=64 Participants RE-021 (Sparsentan) administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose was 200, 400, or 800mg. Patients at \</= 50kg received half of the RE-021 (Sparsentan) dose for the 8 week duration. RE-021 (Sparsentan): Oral, once-daily	Irbesartan 300 mg Pooled n=32 Participants The control irbesartan was administered as a single oral dose of 150mg for the first week before being escalated to 300mg for the remaining 7 weeks. Patients at \</= 50kg received 150mg irbesartan for the 8 week duration. Irbesartan: Oral, once-daily	RE-021 (Sparsentan) 400 and 800 mg Pooled n=51 Participants RE-021 (Sparsentan) administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose was 400 or 800mg. Patients at \</= 50kg received half of the RE-021 (Sparsentan) dose for the 8 week duration. RE-021 (Sparsentan): Oral, once-daily	RE-021 (Sparsentan) 200mg n=13 Participants RE-021 (Sparsentan) administered as a single oral morning dose. In this group, the RE-021 (Sparsentan) dose was 200mg. Patients at \</= 50kg received half of the RE-021 (Sparsentan) dose for the 8 week duration. RE-021 (Sparsentan): Oral, once-daily	RE-021 (Sparsentan) 400mg n=21 Participants RE-021 (Sparsentan) administered as a single oral morning dose. In this group, the RE-021 (Sparsentan) dose was 400mg. Patients at \</= 50kg received half of the RE-021 (Sparsentan) dose for the 8 week duration. RE-021 (Sparsentan): Oral, once-daily	RE-021 (Sparsentan) 800mg n=30 Participants RE-021 (Sparsentan) administered as a single oral morning dose. In this group, the RE-021 (Sparsentan) dose was 800mg. Patients at \</= 50kg received half of the RE-021 (Sparsentan) dose for the 8 week duration. RE-021 (Sparsentan): Oral, once-daily
Percent Change in Urine Protein/Creatinine (Up/C)	-44.8 percent change Interval -52.7 to -35.7	-18.5 percent change Interval -34.6 to 1.7	-47.4 percent change Interval -56.3 to -36.9	-33.1 percent change Interval -49.3 to -11.6	-52.7 percent change Interval -64.3 to -37.2	-41.3 percent change Interval -54.4 to -24.4

SECONDARY outcome

Timeframe: 8 weeks

Population: Efficacy evaluable set. The sparsentan arms were compared to irbesartan in several different combinations that were defined in the study's Statistical Analysis Plan.

The secondary efficacy endpoint is the proportion of FSGS patients achieving FPRE (experiencing a UP/C ratio ≤1.5 g/g and \>40% reduction from baseline in Up/C) at Week 8 over a range of dose levels compared to treatment with irbesartan as active control.

Outcome measures

Outcome measures
Measure	RE-021 (Sparsentan) 200, 400, 800 mg Pooled n=64 Participants RE-021 (Sparsentan) administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose was 200, 400, or 800mg. Patients at \</= 50kg received half of the RE-021 (Sparsentan) dose for the 8 week duration. RE-021 (Sparsentan): Oral, once-daily	Irbesartan 300 mg Pooled n=32 Participants The control irbesartan was administered as a single oral dose of 150mg for the first week before being escalated to 300mg for the remaining 7 weeks. Patients at \</= 50kg received 150mg irbesartan for the 8 week duration. Irbesartan: Oral, once-daily	RE-021 (Sparsentan) 400 and 800 mg Pooled n=51 Participants RE-021 (Sparsentan) administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose was 400 or 800mg. Patients at \</= 50kg received half of the RE-021 (Sparsentan) dose for the 8 week duration. RE-021 (Sparsentan): Oral, once-daily	RE-021 (Sparsentan) 200mg n=13 Participants RE-021 (Sparsentan) administered as a single oral morning dose. In this group, the RE-021 (Sparsentan) dose was 200mg. Patients at \</= 50kg received half of the RE-021 (Sparsentan) dose for the 8 week duration. RE-021 (Sparsentan): Oral, once-daily	RE-021 (Sparsentan) 400mg n=21 Participants RE-021 (Sparsentan) administered as a single oral morning dose. In this group, the RE-021 (Sparsentan) dose was 400mg. Patients at \</= 50kg received half of the RE-021 (Sparsentan) dose for the 8 week duration. RE-021 (Sparsentan): Oral, once-daily	RE-021 (Sparsentan) 800mg n=30 Participants RE-021 (Sparsentan) administered as a single oral morning dose. In this group, the RE-021 (Sparsentan) dose was 800mg. Patients at \</= 50kg received half of the RE-021 (Sparsentan) dose for the 8 week duration. RE-021 (Sparsentan): Oral, once-daily
Percentage of Patients Achieving FSGS Partial Remission Endpoint (FPRE)	28.13 percentage of patients	9.38 percentage of patients	31.37 percentage of patients	15.38 percentage of patients	38.10 percentage of patients	26.67 percentage of patients

Adverse Events

RE-021 (Sparsentan) 200 mg - Double-Blind Period

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

RE-021 (Sparsentan) 400 mg - Double-Blind Period

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

RE-021 (Sparsentan) 800 mg - Double-Blind Period

Serious events: 2 serious events

Other events: 27 other events

Deaths: 0 deaths

Irbesartan 300 mg - Double-Blind Period

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

All Sparsentan (Double-Blind and Open-Label Extension)

Serious events: 48 serious events

Other events: 104 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RE-021 (Sparsentan) 200 mg - Double-Blind Period n=13 participants at risk Sparsentan (RE-021) administered as a single oral morning dose. In this ARM the sparsentan (RE-021) dose was 200mg. Patients at \</= 50kg received half the sparsentan (RE-021) dose for the 8 week duration. Sparsentan (RE-021): Oral, once-daily	RE-021 (Sparsentan) 400 mg - Double-Blind Period n=26 participants at risk Sparsentan (RE-021) administered as a single oral morning dose. In this ARM the sparsentan (RE-021) dose was 400mg. Patients at \</= 50kg received half the sparsentan (RE-021) dose for the 8 week duration. Sparsentan (RE-021): Oral, once-daily	RE-021 (Sparsentan) 800 mg - Double-Blind Period n=34 participants at risk Sparsentan (RE-021) administered as a single oral morning dose. In this ARM the sparsentan (RE-021) dose was 800mg. Patients at \</= 50kg received half of the sparsentan (RE-021) dose for the 8 week duration. Sparsentan (RE-021): Oral, once-daily	Irbesartan 300 mg - Double-Blind Period n=36 participants at risk The control irbesartan was administered as a single oral dose of 150mg for the first week before escalating to 300mg for the remaining 7 weeks. Patients at \</= 50kg received 150mg irbesartan for the 8 week duration. Irbesartan: Oral, once-daily	All Sparsentan (Double-Blind and Open-Label Extension) n=108 participants at risk Double-blind and open-label extension data for all patients while on sparsentan (RE-021). This includes double-blind and open-label extension data for subjects randomized to sparsentan, and only open-label extension data for subjects randomized to irbesartan. Sparsentan (RE-021): Oral, once-daily
Renal and urinary disorders Acute kidney injury	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	9.3% 10/108 • Number of events 11 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Renal and urinary disorders Proteinuria	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.8% 3/108 • Number of events 3 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Renal and urinary disorders End stage renal disease	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	1.9% 2/108 • Number of events 2 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Renal and urinary disorders Chronic kidney disease	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Renal and urinary disorders Nephrotic syndrome	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Renal and urinary disorders Renal failure	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Renal and urinary disorders Renal impairment	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Renal and urinary disorders Subcapsular renal haematoma	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Renal and urinary disorders Urinary retention	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Infections and infestations COVID-19	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	9.3% 10/108 • Number of events 11 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Infections and infestations Pneumonia	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	3.7% 4/108 • Number of events 4 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Infections and infestations Abscess limb	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Infections and infestations Appendicitis	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Infections and infestations Gastroenteritis	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Infections and infestations Sepsis	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Infections and infestations Septic shock	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
General disorders Chest pain	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	3.7% 4/108 • Number of events 4 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
General disorders Oedema	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	1.9% 2/108 • Number of events 2 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
General disorders Chest discomfort	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
General disorders Drug withdrawal syndrome	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.9% 1/34 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
General disorders Generalised oedema	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
General disorders Pyrexia	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.8% 3/108 • Number of events 4 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	1.9% 2/108 • Number of events 2 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Metabolism and nutrition disorders Dehydration	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.8% 1/36 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/108 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Gastrointestinal disorders Abdominal pain	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Gastrointestinal disorders Anal fistula	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Gastrointestinal disorders Ascites	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Gastrointestinal disorders Colitis	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Gastrointestinal disorders Erosive oesophagitis	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Gastrointestinal disorders Gastritis	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Gastrointestinal disorders Inguinal hernia	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Gastrointestinal disorders Melaena	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Vascular disorders Deep vein thrombosis	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	1.9% 2/108 • Number of events 2 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Vascular disorders Angiopathy	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Vascular disorders Haematoma	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Vascular disorders Hypertensive urgency	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Vascular disorders Hypotension	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Vascular disorders Jugular vein thrombosis	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Cardiac disorders Atrial fibrillation	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	1.9% 2/108 • Number of events 2 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Cardiac disorders Aortic valve stenosis	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Cardiac disorders Conduction disorder	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Cardiac disorders Coronary artery stenosis	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Cardiac disorders Sinus bradycardia	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.9% 1/34 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Musculoskeletal and connective tissue disorders Bone infarction	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Blood and lymphatic system disorders Anaemia	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	1.9% 2/108 • Number of events 2 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 2 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Injury, poisoning and procedural complications Jaw fracture	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Angioimmunoblastic T-cell lymphoma	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Nervous system disorders Syncope	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.9% 1/34 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.8% 3/108 • Number of events 3 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Respiratory, thoracic and mediastinal disorders Apnoea	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.9% 1/34 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Investigations Glomerular filtration rate decreased	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Investigations Pulse absent	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.9% 1/34 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Endocrine disorders Hyperaldosteronism	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Hepatobiliary disorders Liver injury	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Psychiatric disorders Anxiety	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Psychiatric disorders Depression	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.

Other adverse events

Other adverse events
Measure	RE-021 (Sparsentan) 200 mg - Double-Blind Period n=13 participants at risk Sparsentan (RE-021) administered as a single oral morning dose. In this ARM the sparsentan (RE-021) dose was 200mg. Patients at \</= 50kg received half the sparsentan (RE-021) dose for the 8 week duration. Sparsentan (RE-021): Oral, once-daily	RE-021 (Sparsentan) 400 mg - Double-Blind Period n=26 participants at risk Sparsentan (RE-021) administered as a single oral morning dose. In this ARM the sparsentan (RE-021) dose was 400mg. Patients at \</= 50kg received half the sparsentan (RE-021) dose for the 8 week duration. Sparsentan (RE-021): Oral, once-daily	RE-021 (Sparsentan) 800 mg - Double-Blind Period n=34 participants at risk Sparsentan (RE-021) administered as a single oral morning dose. In this ARM the sparsentan (RE-021) dose was 800mg. Patients at \</= 50kg received half of the sparsentan (RE-021) dose for the 8 week duration. Sparsentan (RE-021): Oral, once-daily	Irbesartan 300 mg - Double-Blind Period n=36 participants at risk The control irbesartan was administered as a single oral dose of 150mg for the first week before escalating to 300mg for the remaining 7 weeks. Patients at \</= 50kg received 150mg irbesartan for the 8 week duration. Irbesartan: Oral, once-daily	All Sparsentan (Double-Blind and Open-Label Extension) n=108 participants at risk Double-blind and open-label extension data for all patients while on sparsentan (RE-021). This includes double-blind and open-label extension data for subjects randomized to sparsentan, and only open-label extension data for subjects randomized to irbesartan. Sparsentan (RE-021): Oral, once-daily
Investigations Blood triglycerides increased	7.7% 1/13 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.8% 1/36 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.8% 3/108 • Number of events 5 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Investigations Blood potassium increased	7.7% 1/13 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	1.9% 2/108 • Number of events 3 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Nervous system disorders Headache	23.1% 3/13 • Number of events 4 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	7.7% 2/26 • Number of events 2 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	26.5% 9/34 • Number of events 11 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	19.4% 7/36 • Number of events 7 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	29.6% 32/108 • Number of events 43 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Infections and infestations COVID-19	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	15.7% 17/108 • Number of events 19 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Infections and infestations Upper respiratory tract infection	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	5.9% 2/34 • Number of events 3 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	5.6% 2/36 • Number of events 2 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	15.7% 17/108 • Number of events 43 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Infections and infestations Nasopharyngitis	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.9% 1/34 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	12.0% 13/108 • Number of events 23 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Infections and infestations Urinary tract infection	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	3.8% 1/26 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	10.2% 11/108 • Number of events 22 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Infections and infestations Influenza	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.9% 1/34 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	8.3% 9/108 • Number of events 10 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Infections and infestations Sinusitis	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	3.8% 1/26 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	7.4% 8/108 • Number of events 11 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Infections and infestations Bronchitis	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	3.8% 1/26 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	6.5% 7/108 • Number of events 10 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Infections and infestations Cellulitis	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	5.6% 6/108 • Number of events 6 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Infections and infestations Pneumonia	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	5.6% 6/108 • Number of events 6 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Gastrointestinal disorders Diarrhoea	7.7% 1/13 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	3.8% 1/26 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	11.8% 4/34 • Number of events 4 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.8% 1/36 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	25.0% 27/108 • Number of events 36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Gastrointestinal disorders Nausea	7.7% 1/13 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	11.5% 3/26 • Number of events 3 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	14.7% 5/34 • Number of events 6 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	8.3% 3/36 • Number of events 3 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	24.1% 26/108 • Number of events 37 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Gastrointestinal disorders Vomiting	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	11.5% 3/26 • Number of events 3 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	8.8% 3/34 • Number of events 5 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.8% 1/36 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	17.6% 19/108 • Number of events 30 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Gastrointestinal disorders Abdominal pain	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.8% 1/36 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	6.5% 7/108 • Number of events 10 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	3.8% 1/26 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	8.8% 3/34 • Number of events 3 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	5.6% 2/36 • Number of events 2 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	5.6% 6/108 • Number of events 7 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	5.6% 6/108 • Number of events 6 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Gastrointestinal disorders Dyspepsia	7.7% 1/13 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	3.8% 1/26 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	4.6% 5/108 • Number of events 6 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Gastrointestinal disorders Abdominal discomfort	7.7% 1/13 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	1.9% 2/108 • Number of events 2 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
General disorders Oedema peripheral	7.7% 1/13 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	7.7% 2/26 • Number of events 2 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	5.9% 2/34 • Number of events 2 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.8% 1/36 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	27.8% 30/108 • Number of events 45 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
General disorders Pyrexia	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	3.8% 1/26 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.9% 1/34 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	14.8% 16/108 • Number of events 19 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
General disorders Fatigue	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	3.8% 1/26 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	5.9% 2/34 • Number of events 3 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	11.1% 4/36 • Number of events 4 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	11.1% 12/108 • Number of events 15 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
General disorders Chest pain	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.9% 1/34 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	9.3% 10/108 • Number of events 14 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
General disorders Asthenia	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.9% 1/34 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	5.6% 6/108 • Number of events 8 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
General disorders Oedema	7.7% 1/13 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	8.8% 3/34 • Number of events 3 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	3.7% 4/108 • Number of events 4 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
General disorders Local swelling	7.7% 1/13 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/108 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Investigations Blood creatine phosphokinase increased	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	3.8% 1/26 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.8% 1/36 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	15.7% 17/108 • Number of events 21 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Investigations Blood creatinine increased	7.7% 1/13 • Number of events 2 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	3.8% 1/26 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.9% 1/34 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.8% 1/36 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	14.8% 16/108 • Number of events 23 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Investigations Glomerular filtration rate decreased	7.7% 1/13 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.9% 1/34 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	10.2% 11/108 • Number of events 15 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Investigations Haemoglobin decreased	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.8% 1/36 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	6.5% 7/108 • Number of events 7 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Investigations N-terminal prohormone brain natriuretic peptide increased	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	3.8% 1/26 • Number of events 3 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.9% 1/34 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	5.6% 6/108 • Number of events 8 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Nervous system disorders Dizziness	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	15.4% 4/26 • Number of events 4 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	17.6% 6/34 • Number of events 6 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	11.1% 4/36 • Number of events 4 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	17.6% 19/108 • Number of events 28 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Nervous system disorders Paraesthesia	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	11.5% 3/26 • Number of events 3 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.8% 1/36 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	4.6% 5/108 • Number of events 5 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.8% 1/36 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	17.6% 19/108 • Number of events 28 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.8% 1/36 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	13.0% 14/108 • Number of events 15 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	5.6% 2/36 • Number of events 2 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	10.2% 11/108 • Number of events 13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.8% 1/36 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	9.3% 10/108 • Number of events 15 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	6.5% 7/108 • Number of events 8 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	5.6% 6/108 • Number of events 7 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	5.6% 6/108 • Number of events 6 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Metabolism and nutrition disorders Hyperkalaemia	7.7% 1/13 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	5.6% 2/36 • Number of events 3 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	20.4% 22/108 • Number of events 41 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Metabolism and nutrition disorders Gout	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.9% 1/34 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	13.9% 15/108 • Number of events 29 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Metabolism and nutrition disorders Metabolic acidosis	7.7% 1/13 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	9.3% 10/108 • Number of events 12 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Metabolism and nutrition disorders Dehydration	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	3.8% 1/26 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	5.6% 6/108 • Number of events 7 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	5.6% 6/108 • Number of events 6 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Skin and subcutaneous tissue disorders Rash	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	3.8% 1/26 • Number of events 2 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.8% 1/36 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	6.5% 7/108 • Number of events 9 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Vascular disorders Hypotension	7.7% 1/13 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	11.5% 3/26 • Number of events 3 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	17.6% 6/34 • Number of events 6 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	8.3% 3/36 • Number of events 3 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	21.3% 23/108 • Number of events 38 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Vascular disorders Hypertension	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.8% 1/36 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	17.6% 19/108 • Number of events 30 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Vascular disorders Orthostatic hypotension	7.7% 1/13 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.9% 1/34 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	3.7% 4/108 • Number of events 5 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Renal and urinary disorders Acute kidney injury	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.9% 1/34 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	13.9% 15/108 • Number of events 22 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Renal and urinary disorders Proteinuria	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	13.9% 15/108 • Number of events 21 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Renal and urinary disorders Renal impairment	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	5.6% 6/108 • Number of events 7 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Injury, poisoning and procedural complications Contusion	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.8% 1/36 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	6.5% 7/108 • Number of events 8 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	5.6% 6/108 • Number of events 9 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	3.8% 1/26 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	5.9% 2/34 • Number of events 2 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	5.6% 2/36 • Number of events 3 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	12.0% 13/108 • Number of events 18 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	5.9% 2/34 • Number of events 2 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	11.1% 4/36 • Number of events 4 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	11.1% 12/108 • Number of events 17 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.7% 1/13 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	3.8% 1/26 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.9% 1/34 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	10.2% 11/108 • Number of events 18 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	7.4% 8/108 • Number of events 8 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.9% 1/34 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	5.6% 6/108 • Number of events 6 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Skin and subcutaneous tissue disorders Eczema	7.7% 1/13 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.8% 3/108 • Number of events 3 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Skin and subcutaneous tissue disorders Rash papular	7.7% 1/13 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Blood and lymphatic system disorders Anaemia	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	7.7% 2/26 • Number of events 2 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.9% 1/34 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	17.6% 19/108 • Number of events 20 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Reproductive system and breast disorders Oligomenorrhoea	7.7% 1/13 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.93% 1/108 • Number of events 2 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Psychiatric disorders Insomnia	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	3.8% 1/26 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	10.2% 11/108 • Number of events 11 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Ear and labyrinth disorders Tinnitus	7.7% 1/13 • Number of events 1 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/34 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	3.7% 4/108 • Number of events 4 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/13 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/26 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	5.9% 2/34 • Number of events 3 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	0.00% 0/36 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.	2.8% 3/108 • Number of events 6 • For double-blind treatment arms: 8 weeks. For all sparsentan analysis including the open-label extension period: up to 508 weeks. Adverse Events are reported for each treatment arm in the Double-Blind period and for sparsentan-treated patients across the entire study (Double-Blind and Open-Label Extension periods). As one objective of the study was to evaluate the long-term safety of sparsentan, the sparsentan safety results for the entire study are presented in the "All Sparsentan (Double-Blind and Open-Label Extension)" reporting group as pre-specified in the study's Statistical Analysis Plan.

Additional Information

Jula Inrig, MD

Travere Therapeutics, Inc.

Phone: 1-445-529-6312

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place