Trial Outcomes & Findings for A 2-Part, Phase 2 Open-label and Crossover Study of Belumosudil for Treatment of Idiopathic Pulmonary Fibrosis (NCT NCT02688647)

NCT ID: NCT02688647

Last Updated: 2022-09-08

Results Overview

Changes in the mean Forced Vital Capacity (FVC) from baseline at Week 24. Normal FVC-- Healthy males 20 to 60 years: 4.75 to 5.5 L; healthy females 20 to 60 years: 3.25 to 3.75 L

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 76 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2022-09-08

Participant Flow

A total of 76 unique subjects were randomized in this study. Subjects were randomized to belumosudil 400 mg PO QD or Best Standard of Care (BSC) for first 24 weeks. Subjects were randomized to belumosudil had the option of continuing treatment with belumosudil. No subject in either randomized group were permitted > 96 weeks of treatment. After 24 weeks, subjects randomized to BSC were permitted to crossover to belumosudil; 17 subjects crossed over.

Participant milestones

Measure	Belumosudil-R Subjects randomized to treatment with belumosudil 400 mg orally (PO) once daily 9QD).	BSC-R Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.
Initial Treatment Period (24 Weeks) STARTED	52	24
Initial Treatment Period (24 Weeks) Treated	51	24
Initial Treatment Period (24 Weeks) COMPLETED	51	18
Initial Treatment Period (24 Weeks) NOT COMPLETED	1	6
Post Switch Treatment Period (72 Weeks) STARTED	51	17
Post Switch Treatment Period (72 Weeks) COMPLETED	23	3
Post Switch Treatment Period (72 Weeks) NOT COMPLETED	28	14

Reasons for withdrawal

Measure	Belumosudil-R Subjects randomized to treatment with belumosudil 400 mg orally (PO) once daily 9QD).	BSC-R Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.
Initial Treatment Period (24 Weeks) Death	0	1
Initial Treatment Period (24 Weeks) Cross-overed before Initial Treatment Period (24 Weeks)	0	5
Initial Treatment Period (24 Weeks) Subject was randomized but did not receive treatment	1	0
Post Switch Treatment Period (72 Weeks) Death	7	2
Post Switch Treatment Period (72 Weeks) Lost to Follow-up	1	0
Post Switch Treatment Period (72 Weeks) Other	10	6
Post Switch Treatment Period (72 Weeks) Withdrawal by Subject	10	6

Baseline Characteristics

A 2-Part, Phase 2 Open-label and Crossover Study of Belumosudil for Treatment of Idiopathic Pulmonary Fibrosis

Baseline characteristics by cohort

Measure	Belumosudil 400 mg PO QD n=51 Participants Randomized to treatment with belumosudil 400 mg (two 200-mg tablets) orally once daily.	BSC-R n=24 Participants Subjects randomized to treatment with best supportive care for 24 weeks.	Total n=75 Participants Total of all reporting groups
Age, Continuous	72.5 years STANDARD_DEVIATION 7.0 • n=93 Participants	74.9 years STANDARD_DEVIATION 5.9 • n=4 Participants	73.3 years STANDARD_DEVIATION 6.7 • n=27 Participants
Sex: Female, Male Female	13 Participants n=93 Participants	6 Participants n=4 Participants	19 Participants n=27 Participants
Sex: Female, Male Male	38 Participants n=93 Participants	18 Participants n=4 Participants	56 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=93 Participants	0 Participants n=4 Participants	6 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=93 Participants	24 Participants n=4 Participants	69 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) White	49 Participants n=93 Participants	24 Participants n=4 Participants	73 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Prior Use of Pirfenidone Yes	13 Participants n=93 Participants	4 Participants n=4 Participants	17 Participants n=27 Participants
Prior Use of Pirfenidone No	38 Participants n=93 Participants	20 Participants n=4 Participants	58 Participants n=27 Participants
Prior Use of Nintedanib Yes	10 Participants n=93 Participants	4 Participants n=4 Participants	14 Participants n=27 Participants
Prior Use of Nintedanib No	41 Participants n=93 Participants	20 Participants n=4 Participants	61 Participants n=27 Participants
Prior Use of Pirfenidone or Nintedanib Yes	19 Participants n=93 Participants	6 Participants n=4 Participants	25 Participants n=27 Participants
Prior Use of Pirfenidone or Nintedanib No	32 Participants n=93 Participants	18 Participants n=4 Participants	50 Participants n=27 Participants
GAP Stage Stage I	11 Participants n=93 Participants	7 Participants n=4 Participants	18 Participants n=27 Participants
GAP Stage Stage II	31 Participants n=93 Participants	12 Participants n=4 Participants	43 Participants n=27 Participants
GAP Stage Stage III	9 Participants n=93 Participants	5 Participants n=4 Participants	14 Participants n=27 Participants
Presence of Aggravated Dyspnea Within 6 Months Prior to Informed Consent Yes	18 Participants n=93 Participants	11 Participants n=4 Participants	29 Participants n=27 Participants
Presence of Aggravated Dyspnea Within 6 Months Prior to Informed Consent No	33 Participants n=93 Participants	13 Participants n=4 Participants	46 Participants n=27 Participants
Presence of Chest Interstitial Lung Abnormalities Within 6 Months Prior to Informed Consent Yes	23 Participants n=93 Participants	11 Participants n=4 Participants	34 Participants n=27 Participants
Presence of Chest Interstitial Lung Abnormalities Within 6 Months Prior to Informed Consent No	28 Participants n=93 Participants	13 Participants n=4 Participants	41 Participants n=27 Participants
SpO2 < 88% Within 6 Months Prior to Informed Consent Yes	7 Participants n=93 Participants	4 Participants n=4 Participants	11 Participants n=27 Participants
SpO2 < 88% Within 6 Months Prior to Informed Consent No	44 Participants n=93 Participants	20 Participants n=4 Participants	64 Participants n=27 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Analysis was performed using randomized population. Available data for change from baseline at Week 24 have been reported.

Changes in the mean Forced Vital Capacity (FVC) from baseline at Week 24. Normal FVC-- Healthy males 20 to 60 years: 4.75 to 5.5 L; healthy females 20 to 60 years: 3.25 to 3.75 L

Outcome measures

Measure	Belumosudil-R n=52 Participants Subjects randomized to treatment with belumosudil 400 mg orally (PO) once daily 9QD)	BSC-R n=24 Participants Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	Belumosudil-WC n=69 Participants Subjects randomized to treatment with belumosudil 400 mg PO QD plus subjects randomized to treatment with BSC but cross over to treatment with belumosudil 400 mg PO QD	BSC-NC n=24 Participants Subjects randomized to treatment with BSC and who cross over to treatment with belumosudil 400 mg PO QD but have data censored by the date of crossover	Total n=76 Participants Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Efficacy: Mean Changes in FVC From Baseline to Week 24 Baseline	2608.2 mL Standard Deviation 829.6	2516.7 mL Standard Deviation 741.8	2608.8 mL Standard Deviation 840.4	2516.7 mL Standard Deviation 741.8	2569.3 mL Standard Deviation 794.3
Efficacy: Mean Changes in FVC From Baseline to Week 24 At Week 24	2626.8 mL Standard Deviation 886.9	2438.1 mL Standard Deviation 757.1	2617.4 mL Standard Deviation 890.8	2436.8 mL Standard Deviation 784.5	2533.7 mL Standard Deviation 832.7
Efficacy: Mean Changes in FVC From Baseline to Week 24 Change at Week 24	-115.8 mL Standard Deviation 330.3	-71.2 mL Standard Deviation 254.2	-110.8 mL Standard Deviation 316.4	-103.4 mL Standard Deviation 225.0	-99.5 mL Standard Deviation 281.4

PRIMARY outcome

Timeframe: 24 weeks

Population: Analysis was performed using randomized population. Available data for change from baseline at Week 24 have been reported.

Changes in the mean Forced Vital Capacity (FVC)% Predicted from baseline at Week 24.

Normal FVC%: 80% to 120%

Outcome measures

Measure	Belumosudil-R n=52 Participants Subjects randomized to treatment with belumosudil 400 mg orally (PO) once daily 9QD)	BSC-R n=24 Participants Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	Belumosudil-WC n=69 Participants Subjects randomized to treatment with belumosudil 400 mg PO QD plus subjects randomized to treatment with BSC but cross over to treatment with belumosudil 400 mg PO QD	BSC-NC n=24 Participants Subjects randomized to treatment with BSC and who cross over to treatment with belumosudil 400 mg PO QD but have data censored by the date of crossover	Total n=76 Participants Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Efficacy: Mean Changes in FVC% Predicted From Baseline at Week 24 Baseline	69.61 % of predicted Standard Deviation 18.07	68.46 % of predicted Standard Deviation 15.63	69.73 % of predicted Standard Deviation 17.70	68.46 % of predicted Standard Deviation 15.63	69.19 % of predicted Standard Deviation 16.71
Efficacy: Mean Changes in FVC% Predicted From Baseline at Week 24 At Week 24	69.71 % of predicted Standard Deviation 19.20	68.29 % of predicted Standard Deviation 13.41	69.96 % of predicted Standard Deviation 18.43	68.58 % of predicted Standard Deviation 13.98	69.24 % of predicted Standard Deviation 16.25
Efficacy: Mean Changes in FVC% Predicted From Baseline at Week 24 Change at Week 24	-2.82 % of predicted Standard Deviation 7.57	-2.00 % of predicted Standard Deviation 7.36	-2.66 % of predicted Standard Deviation 7.49	-3.00 % of predicted Standard Deviation 6.41	-2.58 % of predicted Standard Deviation 7.16

PRIMARY outcome

Timeframe: Up to 96 weeks (Weeks 24, 48, and 96) of treatment with belumosudil. Subjects randomized to BSC had the option of crossing over at 24 weeks.

Population: All subjects treated in study.

Percentage of subjects with non-serious TEAEs by relationship to treatment with belumosudil, BSC, or belumosudil and BSC.

Severity of TEAEs were measured using the Common Terminology Criteria for Adverse Events (CTCAE) version 22.1 (Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = fatal).

Outcome measures

Measure	Belumosudil-R n=51 Participants Subjects randomized to treatment with belumosudil 400 mg orally (PO) once daily 9QD)	BSC-R n=24 Participants Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	Belumosudil-WC n=68 Participants Subjects randomized to treatment with belumosudil 400 mg PO QD plus subjects randomized to treatment with BSC but cross over to treatment with belumosudil 400 mg PO QD	BSC-NC n=24 Participants Subjects randomized to treatment with BSC and who cross over to treatment with belumosudil 400 mg PO QD but have data censored by the date of crossover	Total n=75 Participants Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Safety: Percentages of Subjects With Non-serious TEAEs and Relationship to Study Treatment TEAEs Related to Treatment (All Grades)	23 Participants	9 Participants	32 Participants	2 Participants	32 Participants
Safety: Percentages of Subjects With Non-serious TEAEs and Relationship to Study Treatment TEAEs Related to Treatment (Only Grades 3 & 4)	2 Participants	0 Participants	2 Participants	0 Participants	2 Participants

PRIMARY outcome

Timeframe: Up to 96 weeks (Weeks 24, 48, and 96) of treatment with belumosudil. Subjects randomized to BSC and crossing over also up to 24 weeks of BSC.

Population: All subjects treated in study.

Percentage of subjects with serious TEAEs by relationship to treatment with belumosudil and/or BSC.

Investigators assessed whether events were related to treatment as possibly, probably, or definitely related.

Outcome measures

Measure	Belumosudil-R n=51 Participants Subjects randomized to treatment with belumosudil 400 mg orally (PO) once daily 9QD)	BSC-R n=24 Participants Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	Belumosudil-WC n=68 Participants Subjects randomized to treatment with belumosudil 400 mg PO QD plus subjects randomized to treatment with BSC but cross over to treatment with belumosudil 400 mg PO QD	BSC-NC n=24 Participants Subjects randomized to treatment with BSC and who cross over to treatment with belumosudil 400 mg PO QD but have data censored by the date of crossover	Total n=75 Participants Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Safety: Percentages of Subjects With SAEs Related to Study Treatment	2 Participants	0 Participants	2 Participants	0 Participants	2 Participants

PRIMARY outcome

Timeframe: Up to 96 weeks (Weeks 24, 48, and 96) of treatment with belumosudil

Population: Subjects who received belumosudil 400 mg PO QD were included. Subjects who only received BSC and did not cross over to treatment with belumosudil were not included.

Percentage of subjects with treatment-emergent adverse events (TEAEs) leading to subjects discontinuing from treatment.

Investigators assessed whether TEAEs leading to discontinuation were related to study drug (possibly, probably, or definitely), belumosudil 400 mg PO QD.

Outcome measures

Measure	Belumosudil-R n=51 Participants Subjects randomized to treatment with belumosudil 400 mg orally (PO) once daily 9QD)	BSC-R n=24 Participants Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	Belumosudil-WC n=68 Participants Subjects randomized to treatment with belumosudil 400 mg PO QD plus subjects randomized to treatment with BSC but cross over to treatment with belumosudil 400 mg PO QD	BSC-NC n=75 Participants Subjects randomized to treatment with BSC and who cross over to treatment with belumosudil 400 mg PO QD but have data censored by the date of crossover	Total Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Safety: Percentages of Subjects With TEAEs Leading to Discontinuation of Treatment With Belumosudil All TEAEs Leading to Discontinuation	14 Participants	8 Participants	22 Participants	22 Participants	—
Safety: Percentages of Subjects With TEAEs Leading to Discontinuation of Treatment With Belumosudil TEAEs Related to Belumosudil Leading to Study Discontinuation	5 Participants	1 Participants	6 Participants	6 Participants	—

PRIMARY outcome

Timeframe: Up to 96 weeks (Weeks 24, 8, and 96) of treatment with belumosudil. Subjects randomized to BSC also had the option of crossing over to treatment with belumosudil at 24 weeks.

Population: All subjects treated in study.

Percentage of subjects with deaths by relationship to treatment with belumosudil, BSC, or belumosudil and BSC.

Investigators assessed whether events were related to treatment as possibly, probably, or definitely related.

Outcome measures

Measure	Belumosudil-R n=51 Participants Subjects randomized to treatment with belumosudil 400 mg orally (PO) once daily 9QD)	BSC-R n=24 Participants Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	Belumosudil-WC n=68 Participants Subjects randomized to treatment with belumosudil 400 mg PO QD plus subjects randomized to treatment with BSC but cross over to treatment with belumosudil 400 mg PO QD	BSC-NC n=19 Participants Subjects randomized to treatment with BSC and who cross over to treatment with belumosudil 400 mg PO QD but have data censored by the date of crossover	Total n=75 Participants Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Safety: Percentages of Subjects With Deaths Related to Study Treatment	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: The Modified Intent-to-Treat (mITT) Population was used which consisted of all subjects in the Safety Population who had an evaluable baseline and ≥ 1 evaluable post baseline assessment.

Changes in the mean Forced Vital Capacities (FVC) at Week 24 by Gender/Age/Physiology (GAP) Stage and by the previous use of pirfenidone and/or nintedanib prior to the study for Belumosudil-WC compared to BSC-NC.

Normal FVC--Healthy males 20 to 60 years: 4.75 to 5.5 L; healthy famles 20 to 60 years: 3.25 to 3.75 L

GAP is measured by points as follows:

(G) Gender: Female = 0 points; Male = 1 point (A) Age: ≤ 60 years = 0 points; 61-65 years = 1 point; > 65 years = 2 points (P) Physiology:

• FVC% Predicted: > 75% = 0 points; 50-75% = 1 point; ≤ 50% = 2 points
• DLCO% (diffusing lung capacity of carbon monoxide by % predicted) Predicted: > 55% = 0 points; 36-55% = 1 point, ≤ 35% = 2 points; cannot perform = 3 points

GAP Stage:

• Stage I Index = 0 to 3 points
• Stage II Index= 4 to 5 points
• Stage III Index = 6 to 8 points

Outcome measures

Measure	Belumosudil-R n=58 Participants Subjects randomized to treatment with belumosudil 400 mg orally (PO) once daily 9QD)	BSC-R n=21 Participants Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	Belumosudil-WC Subjects randomized to treatment with belumosudil 400 mg PO QD plus subjects randomized to treatment with BSC but cross over to treatment with belumosudil 400 mg PO QD	BSC-NC Subjects randomized to treatment with BSC and who cross over to treatment with belumosudil 400 mg PO QD but have data censored by the date of crossover	Total Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Efficacy: Mean Changes in FVC From Baseline at Week 24 by GAP Stage and by Use of Pirfenidone or Nintedanib-- GAP Stage II	-219.90 mL Interval -416.2 to -23.6	-179.94 mL Interval -444.35 to 84.47	—	—	—
Efficacy: Mean Changes in FVC From Baseline at Week 24 by GAP Stage and by Use of Pirfenidone or Nintedanib-- GAP Stage III	101.95 mL Interval -1246.61 to 1450.5	7.79 mL Interval -1553.37 to 1568.95	—	—	—
Efficacy: Mean Changes in FVC From Baseline at Week 24 by GAP Stage and by Use of Pirfenidone or Nintedanib-- No Prior Use of Pirfenidone or Nintedanib	-80.34 mL Interval -190.81 to 30.14	-46.21 mL Interval -167.93 to 75.51	—	—	—
Efficacy: Mean Changes in FVC From Baseline at Week 24 by GAP Stage and by Use of Pirfenidone or Nintedanib-- GAP Stage I	-117.65 mL Interval -324.28 to 88.98	-156.50 mL Interval -355.39 to 42.4	—	—	—

SECONDARY outcome

Timeframe: Up to 96 weeks (Weeks 24, 48, and 96)

Population: All randomized subjects

Changes in the mean Forced Vital Capacity (FVC) from baseline at Weeks 48 and 96, and End-of-Treatment (EOT) Normal FVC: Healthy males 20 to 60 years: 4.75 to 5.25 L; healthy females 20 to 60 years: 3.25 to 3.75 L

Outcome measures

Measure	Belumosudil-R n=52 Participants Subjects randomized to treatment with belumosudil 400 mg orally (PO) once daily 9QD)	BSC-R n=24 Participants Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	Belumosudil-WC n=69 Participants Subjects randomized to treatment with belumosudil 400 mg PO QD plus subjects randomized to treatment with BSC but cross over to treatment with belumosudil 400 mg PO QD	BSC-NC n=76 Participants Subjects randomized to treatment with BSC and who cross over to treatment with belumosudil 400 mg PO QD but have data censored by the date of crossover	Total Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Efficacy: Mean Changes in FVC From Baseline at Week 48, Week 96, and EOT Baseline	2608.2 mL Standard Deviation 829.6	2516.7 mL Standard Deviation 741.8	2608.8 mL Standard Deviation 840.4	2569.3 mL Standard Deviation 794.3	—
Efficacy: Mean Changes in FVC From Baseline at Week 48, Week 96, and EOT Change at Week 48	-197.2 mL Standard Deviation 331.5	-82.5 mL Standard Deviation 329.7	-199.6 mL Standard Deviation 366.1	-177.8 mL Standard Deviation 358.8	—
Efficacy: Mean Changes in FVC From Baseline at Week 48, Week 96, and EOT Change at Week 96	-141.0 mL Standard Deviation 401.1	-264.0 mL Standard Deviation 896.0	-122.2 mL Standard Deviation 384.3	-147.5 mL Standard Deviation 492.3	—
Efficacy: Mean Changes in FVC From Baseline at Week 48, Week 96, and EOT Change at EOT	-227.9 mL Standard Deviation 367.7	-110.7 mL Standard Deviation 397.7	-207.2 mL Standard Deviation 353.7	-180.9 mL Standard Deviation 355.8	—

SECONDARY outcome

Timeframe: Up to 96 weeks (Weeks 24, 48, and 96)

Population: All randomized subjects

Change in the mean ratio of Forced Expiratory Volume in 1 Second (FEV1) divided by the Forced Vital Capacity (FVC) at Week 24, Week 48, Week 96, and End-of-Treatment (EOT) Normal FEV1: 80% to 120% FEV1/FVC = Within 5% of predicted ratio

Outcome measures

Measure	Belumosudil-R n=52 Participants Subjects randomized to treatment with belumosudil 400 mg orally (PO) once daily 9QD)	BSC-R n=24 Participants Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	Belumosudil-WC n=69 Participants Subjects randomized to treatment with belumosudil 400 mg PO QD plus subjects randomized to treatment with BSC but cross over to treatment with belumosudil 400 mg PO QD	BSC-NC n=24 Participants Subjects randomized to treatment with BSC and who cross over to treatment with belumosudil 400 mg PO QD but have data censored by the date of crossover	Total n=76 Participants Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Efficacy: Mean Change in Mean FEV1/FVC Ratio From Baseline at Weeks 24, 48, and 96 and EOT Change at Week 96	-0.012 Units Standard Deviation 0.0420	-0.014 Units Standard Deviation 0.0378	-0.012 Units Standard Deviation 0.0402	—	-0.012 Units Standard Deviation 0.0391
Efficacy: Mean Change in Mean FEV1/FVC Ratio From Baseline at Weeks 24, 48, and 96 and EOT Change at EOT	-0.010 Units Standard Deviation 0.0362	0.011 Units Standard Deviation 0.0372	-0.011 Units Standard Deviation 0.0453	-0.010 Units Standard Deviation 0	-0.007 Units Standard Deviation 0.0436
Efficacy: Mean Change in Mean FEV1/FVC Ratio From Baseline at Weeks 24, 48, and 96 and EOT Baseline	0.829 Units Standard Deviation 0.0613	0.816 Units Standard Deviation 0.0674	0.832 Units Standard Deviation 0.0584	0.816 Units Standard Deviation 0.0674	0.825 Units Standard Deviation 0.0623
Efficacy: Mean Change in Mean FEV1/FVC Ratio From Baseline at Weeks 24, 48, and 96 and EOT Change at Week 24	-0.006 Units Standard Deviation 0.0444	0.013 Units Standard Deviation 0.0310	-0.005 Units Standard Deviation 0.0410	0.016 Units Standard Deviation 0.0311	0.004 Units Standard Deviation 0.0378
Efficacy: Mean Change in Mean FEV1/FVC Ratio From Baseline at Weeks 24, 48, and 96 and EOT Change at Week 48	0.001 Units Standard Deviation 0.0251	-0.005 Units Standard Deviation 0.0141	-0.001 Units Standard Deviation 0.0249	—	-0.002 Units Standard Deviation 0.0232

SECONDARY outcome

Timeframe: 24 weeks

Population: The Modified Intent-to-Treat (mITT) Population was used which consisted of all subjects in the Safety Population who had an evaluable baseline and ≥ 1 evaluable post baseline assessment.

Changes in the mean Forced Vital Capacities (FVC)% Predicted at Week 24 by Gender/Age/Physiology (GAP) Stage and by the previous use of pirfenidone and/or nintedanib prior to the study for Belumosudil-WC compared to BSC-NC.

GAP is measured by points as follows:

(G) Gender: Female = 0 points; Male = 1 point (A) Age: ≤ 60 years = 0 points; 61-65 years = 1 point; > 65 years = 2 points (P) Physiology:

• FVC% Predicted: > 75% = 0 points; 50-75% = 1 point; ≤ 50% = 2 points
• DLCO% (diffusing lung capacity of carbon monoxide by % predicted) Predicted: > 55% = 0 points; 36-55% = 1 point, ≤ 35% = 2 points; cannot perform = 3 points

GAP Stage:

• Stage I = 0 to 3 points
• Stage II = 4 to 5 points
• Stage III = 6 to 8 points

Outcome measures

Measure	Belumosudil-R n=58 Participants Subjects randomized to treatment with belumosudil 400 mg orally (PO) once daily 9QD)	BSC-R n=21 Participants Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	Belumosudil-WC Subjects randomized to treatment with belumosudil 400 mg PO QD plus subjects randomized to treatment with BSC but cross over to treatment with belumosudil 400 mg PO QD	BSC-NC Subjects randomized to treatment with BSC and who cross over to treatment with belumosudil 400 mg PO QD but have data censored by the date of crossover	Total Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Efficacy: Mean Changes in FVC% Predicted at Week 24 by GAP Stage and by Use of Pirfenidone or Nintedanib-- GAP Stage III	2.34 % of predicted Interval -36.32 to 40.99	-0.15 % of predicted Interval -42.95 to 42.65	—	—	—
Efficacy: Mean Changes in FVC% Predicted at Week 24 by GAP Stage and by Use of Pirfenidone or Nintedanib-- Prior Use of Pirfenidone or Nintedanib	-6.20 % of predicted Interval -58.23 to 45.82	-14.91 % of predicted Interval -92.49 to 62.68	—	—	—
Efficacy: Mean Changes in FVC% Predicted at Week 24 by GAP Stage and by Use of Pirfenidone or Nintedanib-- GAP Stage I	-4.65 % of predicted Interval -11.34 to 2.03	-6.53 % of predicted Interval -13.14 to 0.07	—	—	—
Efficacy: Mean Changes in FVC% Predicted at Week 24 by GAP Stage and by Use of Pirfenidone or Nintedanib-- GAP Stage II	-6.42 % of predicted Interval -11.69 to -1.15	-4.69 % of predicted Interval -11.58 to 2.19	—	—	—

SECONDARY outcome

Timeframe: Up to 96 weeks (Weeks 24, 48, and 96)

Population: The Modified Intent-to-Treat (mITT) Population was used which consisted of all subjects in the Safety Population who had an evaluable baseline and ≥ 1 evaluable post baseline assessment.

Percentage of subjects exhibiting at least a 5% decrease in Forced Vital Capacity (FVC)% Predicted from baseline at Week 24, at Week 48, and at Week 96

Outcome measures

Measure	Belumosudil-R n=46 Participants Subjects randomized to treatment with belumosudil 400 mg orally (PO) once daily 9QD)	BSC-R n=24 Participants Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	Belumosudil-WC n=58 Participants Subjects randomized to treatment with belumosudil 400 mg PO QD plus subjects randomized to treatment with BSC but cross over to treatment with belumosudil 400 mg PO QD	BSC-NC n=21 Participants Subjects randomized to treatment with BSC and who cross over to treatment with belumosudil 400 mg PO QD but have data censored by the date of crossover	Total n=70 Participants Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Efficacy: Percentages of Subjects With Decrease ≥ 5% in FVC% Predicted From Baseline at Weeks 24, 48, and 96 At Week 24: Yes	11 Participants	7 Participants	14 Participants	7 Participants	21 Participants
Efficacy: Percentages of Subjects With Decrease ≥ 5% in FVC% Predicted From Baseline at Weeks 24, 48, and 96 At Week 24: No	27 Participants	14 Participants	32 Participants	12 Participants	42 Participants
Efficacy: Percentages of Subjects With Decrease ≥ 5% in FVC% Predicted From Baseline at Weeks 24, 48, and 96 At Week 48: Yes	14 Participants	4 Participants	16 Participants	—	18 Participants
Efficacy: Percentages of Subjects With Decrease ≥ 5% in FVC% Predicted From Baseline at Weeks 24, 48, and 96 At Week 48: No	15 Participants	4 Participants	19 Participants	—	20 Participants
Efficacy: Percentages of Subjects With Decrease ≥ 5% in FVC% Predicted From Baseline at Weeks 24, 48, and 96 At Week 96: Yes	6 Participants	2 Participants	6 Participants	—	8 Participants
Efficacy: Percentages of Subjects With Decrease ≥ 5% in FVC% Predicted From Baseline at Weeks 24, 48, and 96 At Week 96: No	14 Participants	3 Participants	17 Participants	—	17 Participants

SECONDARY outcome

Timeframe: Up to 96 weeks (Weeks 24, 48, and 96)

Population: The Modified Intent-to-Treat (mITT) Population was used which consisted of all subjects in the Safety Population who had an evaluable baseline and ≥ 1 evaluable post baseline assessment.

Percentage of subjects who exhibited at least a 10% decrease in Forced Vital Capacity (FVC)% Predicted from baseline at Week 24, at Week 48, and at Week 96

Outcome measures

Measure	Belumosudil-R n=46 Participants Subjects randomized to treatment with belumosudil 400 mg orally (PO) once daily 9QD)	BSC-R n=24 Participants Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	Belumosudil-WC n=58 Participants Subjects randomized to treatment with belumosudil 400 mg PO QD plus subjects randomized to treatment with BSC but cross over to treatment with belumosudil 400 mg PO QD	BSC-NC n=21 Participants Subjects randomized to treatment with BSC and who cross over to treatment with belumosudil 400 mg PO QD but have data censored by the date of crossover	Total n=70 Participants Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Efficacy: Percentage of Subjects With Decrease ≥ 10% in FVC% Predicted at Weeks 24, 48, and 96 At Week 24: Yes	5 Participants	4 Participants	6 Participants	4 Participants	10 Participants
Efficacy: Percentage of Subjects With Decrease ≥ 10% in FVC% Predicted at Weeks 24, 48, and 96 At Week 24: No	33 Participants	17 Participants	40 Participants	15 Participants	50 Participants
Efficacy: Percentage of Subjects With Decrease ≥ 10% in FVC% Predicted at Weeks 24, 48, and 96 At Week 48: Yes	7 Participants	1 Participants	9 Participants	—	10 Participants
Efficacy: Percentage of Subjects With Decrease ≥ 10% in FVC% Predicted at Weeks 24, 48, and 96 At Week 48: No	22 Participants	7 Participants	26 Participants	—	30 Participants
Efficacy: Percentage of Subjects With Decrease ≥ 10% in FVC% Predicted at Weeks 24, 48, and 96 At Week 96: Yes	5 Participants	2 Participants	5 Participants	—	7 Participants
Efficacy: Percentage of Subjects With Decrease ≥ 10% in FVC% Predicted at Weeks 24, 48, and 96 At Week 96: No	15 Participants	3 Participants	18 Participants	—	18 Participants

SECONDARY outcome

Timeframe: Up to 96 weeks (Weeks 24, 48, and 96)

Population: All randomized subjects

The mean change in the 6-mile Walking Distance (6MWD), i.e., the distance a subject can walk in 6 minutes, from baseline to Week 24, to Week 48, and to Week 96.

Positive change = improvement; negative change = worsening

Outcome measures

Measure	Belumosudil-R n=52 Participants Subjects randomized to treatment with belumosudil 400 mg orally (PO) once daily 9QD)	BSC-R n=24 Participants Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	Belumosudil-WC n=69 Participants Subjects randomized to treatment with belumosudil 400 mg PO QD plus subjects randomized to treatment with BSC but cross over to treatment with belumosudil 400 mg PO QD	BSC-NC n=24 Participants Subjects randomized to treatment with BSC and who cross over to treatment with belumosudil 400 mg PO QD but have data censored by the date of crossover	Total n=76 Participants Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Efficacy: Mean Change in 6MWD at Weeks 24, 48, and 96 Change at Week 48	-18.33 meters Standard Deviation 102.45	119.00 meters Standard Deviation 364.61	-18.83 meters Standard Deviation 95.33	—	6.23 meters Standard Deviation 178.69
Efficacy: Mean Change in 6MWD at Weeks 24, 48, and 96 Baseline	368.59 meters Standard Deviation 168.84	349.25 meters Standard Deviation 180.40	350.12 meters Standard Deviation 168.88	323.11 meters Standard Deviation 126.64	345.17 meters Standard Deviation 163.88
Efficacy: Mean Change in 6MWD at Weeks 24, 48, and 96 Change at Week 24	-12.11 meters Standard Deviation 101.78	-16.60 meters Standard Deviation 66.80	7.53 meters Standard Deviation 177.88	-0.77 meters Standard Deviation 49.08	-0.04 meters Standard Deviation 140.22
Efficacy: Mean Change in 6MWD at Weeks 24, 48, and 96 Change at Week 96	-23.06 meters Standard Deviation 78.84	-47.80 meters Standard Deviation 69.80	-20.98 meters Standard Deviation 72.80	—	-26.34 meters Standard Deviation 71.60

SECONDARY outcome

Timeframe: Up to 96 weeks (Weeks 24, 48, and 96)

Population: The Modified Intent-to-Treat (mITT) Population was used which consisted of all subjects in the Safety Population who had an evaluable baseline and ≥ 1 evaluable post baseline assessment.

The percentage of subjects who have at least a 50 meter improvement in the 6-mile Walking Distance (6MWD), i.e., the distance a subject can walk in 6 minutes, from baseline to Week 24, Week 48, and Week 96.

Outcome measures

Measure	Belumosudil-R n=46 Participants Subjects randomized to treatment with belumosudil 400 mg orally (PO) once daily 9QD)	BSC-R n=24 Participants Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	Belumosudil-WC n=58 Participants Subjects randomized to treatment with belumosudil 400 mg PO QD plus subjects randomized to treatment with BSC but cross over to treatment with belumosudil 400 mg PO QD	BSC-NC n=21 Participants Subjects randomized to treatment with BSC and who cross over to treatment with belumosudil 400 mg PO QD but have data censored by the date of crossover	Total n=70 Participants Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Efficacy: Percentages of Subjects With ≥ 50 Meter Improvement in 6MWD at Weeks 24, 48, and 96 ≥ 50 Meter Improvement at Week 24: Yes	6 Participants	4 Participants	8 Participants	2 Participants	11 Participants
Efficacy: Percentages of Subjects With ≥ 50 Meter Improvement in 6MWD at Weeks 24, 48, and 96 ≥ 50 Meter Improvement at Week 24: No	31 Participants	16 Participants	37 Participants	11 Participants	48 Participants
Efficacy: Percentages of Subjects With ≥ 50 Meter Improvement in 6MWD at Weeks 24, 48, and 96 ≥ 50 Meter Improvement at Week 48: Yes	6 Participants	2 Participants	8 Participants	—	10 Participants
Efficacy: Percentages of Subjects With ≥ 50 Meter Improvement in 6MWD at Weeks 24, 48, and 96 ≥ 50 Meter Improvement at Week 48: No	24 Participants	6 Participants	28 Participants	—	32 Participants
Efficacy: Percentages of Subjects With ≥ 50 Meter Improvement in 6MWD at Weeks 24, 48, and 96 ≥ 50 Meter Improvement at Week 96: Yes	5 Participants	2 Participants	5 Participants	—	7 Participants
Efficacy: Percentages of Subjects With ≥ 50 Meter Improvement in 6MWD at Weeks 24, 48, and 96 ≥ 50 Meter Improvement at Week 96: No	12 Participants	3 Participants	15 Participants	—	15 Participants

SECONDARY outcome

Timeframe: Up to 96 weeks (Weeks 24, 48, and 96)

Population: All randomized subjects

The diffusing capacity for carbon dioxide (DLCO) is a measure of the conductance of gas transfer from inspired gas to the red blood cells.

Normal DLCO is > 75% of predicted up to 140%. Severity is generally rated as:

• Mild: 60% to lower limit of normal
• Moderate: 40% to 60%
• Severe: < 40%

Outcome measures

Measure	Belumosudil-R n=52 Participants Subjects randomized to treatment with belumosudil 400 mg orally (PO) once daily 9QD)	BSC-R n=24 Participants Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	Belumosudil-WC n=69 Participants Subjects randomized to treatment with belumosudil 400 mg PO QD plus subjects randomized to treatment with BSC but cross over to treatment with belumosudil 400 mg PO QD	BSC-NC n=24 Participants Subjects randomized to treatment with BSC and who cross over to treatment with belumosudil 400 mg PO QD but have data censored by the date of crossover	Total n=76 Participants Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Efficacy: Mean Changes in DLCO (%) at Weeks 24, 48, and 96 Baseline	47.3 % of diffusing capacity of CO Standard Deviation 11.7	47.3 % of diffusing capacity of CO Standard Deviation 9.9	47.1 % of diffusing capacity of CO Standard Deviation 12.0	48.0 % of diffusing capacity of CO Standard Deviation 10.2	47.3 % of diffusing capacity of CO Standard Deviation 11.1
Efficacy: Mean Changes in DLCO (%) at Weeks 24, 48, and 96 Change at Week 24	-2.7 % of diffusing capacity of CO Standard Deviation 9.5	-3.8 % of diffusing capacity of CO Standard Deviation 5.4	-3.1 % of diffusing capacity of CO Standard Deviation 9.3	-4.5 % of diffusing capacity of CO Standard Deviation 5.6	-3.6 % of diffusing capacity of CO Standard Deviation 7.7
Efficacy: Mean Changes in DLCO (%) at Weeks 24, 48, and 96 Change at Week 48	-2.9 % of diffusing capacity of CO Standard Deviation 8.3	-7.1 % of diffusing capacity of CO Standard Deviation 12.7	-3.2 % of diffusing capacity of CO Standard Deviation 8.0	—	-3.9 % of diffusing capacity of CO Standard Deviation 9.0
Efficacy: Mean Changes in DLCO (%) at Weeks 24, 48, and 96 Change at Week 96	-4.2 % of diffusing capacity of CO Standard Deviation 11.3	-13.7 % of diffusing capacity of CO Standard Deviation 17.7	-6.0 % of diffusing capacity of CO Standard Deviation 11.4	—	-8.2 % of diffusing capacity of CO Standard Deviation 13.4

SECONDARY outcome

Timeframe: Up to 96 weeks (Weeks 24, 48, and 96)

Population: The Modified Intent-to-Treat (mITT) Population was used which consisted of all subjects in the Safety Population who had an evaluable baseline and ≥ 1 evaluable post baseline assessment.

Percentage of the number of subjects who exhibit less than a -15% decrease in diffusing capacity of carbon monoxide (DLCO), measured as % from baseline at Week 24, Week 48, and Week 96

The diffusing capacity for carbon dioxide (DLCO) is a measure of the conductance of gas transfer from inspired gas to the red blood cells.

Normal DLCO is > 75% of predicted up to 140%. Severity is generally rated as:

• Mild: 60% to lower limit of normal
• Moderate: 40% to 60%
• Severe: < 40%

Outcome measures

Measure	Belumosudil-R n=46 Participants Subjects randomized to treatment with belumosudil 400 mg orally (PO) once daily 9QD)	BSC-R n=24 Participants Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	Belumosudil-WC n=58 Participants Subjects randomized to treatment with belumosudil 400 mg PO QD plus subjects randomized to treatment with BSC but cross over to treatment with belumosudil 400 mg PO QD	BSC-NC n=21 Participants Subjects randomized to treatment with BSC and who cross over to treatment with belumosudil 400 mg PO QD but have data censored by the date of crossover	Total n=70 Participants Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Efficacy: Percentages of Subjects With Change From Baseline in DLCO (%) ≤ -15% at Weeks 24, 48, and 96 Week 96 Change ≤ -15%: No	7 Participants	1 Participants	8 Participants	—	8 Participants
Efficacy: Percentages of Subjects With Change From Baseline in DLCO (%) ≤ -15% at Weeks 24, 48, and 96 Week 24 Change ≤ -15%: Yes	7 Participants	7 Participants	10 Participants	6 Participants	16 Participants
Efficacy: Percentages of Subjects With Change From Baseline in DLCO (%) ≤ -15% at Weeks 24, 48, and 96 Week 48 Change ≤ -15%: No	18 Participants	4 Participants	23 Participants	—	24 Participants
Efficacy: Percentages of Subjects With Change From Baseline in DLCO (%) ≤ -15% at Weeks 24, 48, and 96 Week 96 Change ≤ -15%: Yes	3 Participants	4 Participants	5 Participants	—	7 Participants
Efficacy: Percentages of Subjects With Change From Baseline in DLCO (%) ≤ -15% at Weeks 24, 48, and 96 Week 24 Change ≤ -15%: No	29 Participants	14 Participants	33 Participants	9 Participants	43 Participants
Efficacy: Percentages of Subjects With Change From Baseline in DLCO (%) ≤ -15% at Weeks 24, 48, and 96 Week 48 Change ≤ -15%: Yes	10 Participants	4 Participants	11 Participants	—	14 Participants

SECONDARY outcome

Timeframe: Up to 96 weeks (Weeks 24, 48, and 96)

Population: The mITT Population was used which consisted of all subjects in the Safety Population who had an evaluable baseline and ≥ 1 evaluable post baseline FVC assessment.

The change in Total Lung Fibrosis mean score from baseline at Weeks 24, 48, and 96. Measurements using quantitative high-resolution computerized tomography (HRCT) and include (1) extent of fibrotic abnormality; (2) fibrosis score; (3) ground glass opacity; (4) honeycombing score; (5) kurtosis of lung voxel intensity; (6) skewness of lung voxel intensity; (7) standard deviation of voxel; (8) CT total lung volume; (9) normal lung; (10) reticular score; and (11) evaluation of change on sequential scans.

The Quantitative Lung Fibrosis (QLF) score measures the extent of reticular patterns with architectural distortion due to fibrosis using a support vector machine classifier. Range: 0 to 100. Higher scores imply greater impairment.

Outcome measures

Measure	Belumosudil-R n=52 Participants Subjects randomized to treatment with belumosudil 400 mg orally (PO) once daily 9QD)	BSC-R n=24 Participants Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	Belumosudil-WC n=69 Participants Subjects randomized to treatment with belumosudil 400 mg PO QD plus subjects randomized to treatment with BSC but cross over to treatment with belumosudil 400 mg PO QD	BSC-NC n=24 Participants Subjects randomized to treatment with BSC and who cross over to treatment with belumosudil 400 mg PO QD but have data censored by the date of crossover	Total n=76 Participants Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Efficacy: Mean Changes in Total Lung Fibrosis Score, by HRCT, From Baseline at Weeks 24, 48, and 96 Change at Week 48	6.51 score on a scale Standard Deviation 11.76	6.23 score on a scale Standard Deviation 13.27	6.01 score on a scale Standard Deviation 11.74	—	6.06 score on a scale Standard Deviation 11.87
Efficacy: Mean Changes in Total Lung Fibrosis Score, by HRCT, From Baseline at Weeks 24, 48, and 96 Change at Week 96	6.36 score on a scale Standard Deviation 10.41	8.47 score on a scale Standard Deviation 21.86	6.36 score on a scale Standard Deviation 10.41	—	6.71 score on a scale Standard Deviation 12.09
Efficacy: Mean Changes in Total Lung Fibrosis Score, by HRCT, From Baseline at Weeks 24, 48, and 96 Change at Week 24	7.36 score on a scale Standard Deviation 11.46	1.08 score on a scale Standard Deviation 6.31	8.00 score on a scale Standard Deviation 12.55	1.41 score on a scale Standard Deviation 6.31	4.67 score on a scale Standard Deviation 10.44
Efficacy: Mean Changes in Total Lung Fibrosis Score, by HRCT, From Baseline at Weeks 24, 48, and 96 Baseline	30.91 score on a scale Standard Deviation 14.54	33.34 score on a scale Standard Deviation 17.81	31.78 score on a scale Standard Deviation 15.48	33.34 score on a scale Standard Deviation 17.81	32.53 score on a scale Standard Deviation 16.45

SECONDARY outcome

Timeframe: Up to 96 weeks (Weeks 24, 48, and 96)

Population: All randomized subjects.

The categorical changes of lung fibrosis using subjective visual assessments by radiologists from sequential scans at baseline, Week 24, Week 48, and Week 96. Changes were categorized as: (1) much better; (2) slightly better; (3) same; (4) slightly worse; and (5) much worse. This categorization is simplified as Better (Much or Slightly); Same; and Worse (Slightly or Much).

Outcome measures

Measure	Belumosudil-R n=46 Participants Subjects randomized to treatment with belumosudil 400 mg orally (PO) once daily 9QD)	BSC-R n=24 Participants Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	Belumosudil-WC n=58 Participants Subjects randomized to treatment with belumosudil 400 mg PO QD plus subjects randomized to treatment with BSC but cross over to treatment with belumosudil 400 mg PO QD	BSC-NC n=21 Participants Subjects randomized to treatment with BSC and who cross over to treatment with belumosudil 400 mg PO QD but have data censored by the date of crossover	Total n=70 Participants Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Efficacy: Categorical Changes in Lung Fibrosis as Observed by Sequential Scans of Radiologist Visual Assessment, From Baseline at Weeks 24, 48, and 96 Week 24: Worse	13 Participants	4 Participants	17 Participants	4 Participants	17 Participants
Efficacy: Categorical Changes in Lung Fibrosis as Observed by Sequential Scans of Radiologist Visual Assessment, From Baseline at Weeks 24, 48, and 96 Week 24: Better	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants
Efficacy: Categorical Changes in Lung Fibrosis as Observed by Sequential Scans of Radiologist Visual Assessment, From Baseline at Weeks 24, 48, and 96 Week 24: Same	22 Participants	13 Participants	25 Participants	11 Participants	35 Participants
Efficacy: Categorical Changes in Lung Fibrosis as Observed by Sequential Scans of Radiologist Visual Assessment, From Baseline at Weeks 24, 48, and 96 Week 48: Better	0 Participants	1 Participants	1 Participants	—	1 Participants
Efficacy: Categorical Changes in Lung Fibrosis as Observed by Sequential Scans of Radiologist Visual Assessment, From Baseline at Weeks 24, 48, and 96 Week 48: Same	6 Participants	1 Participants	6 Participants	—	7 Participants
Efficacy: Categorical Changes in Lung Fibrosis as Observed by Sequential Scans of Radiologist Visual Assessment, From Baseline at Weeks 24, 48, and 96 Week 48: Worse	10 Participants	5 Participants	13 Participants	—	15 Participants
Efficacy: Categorical Changes in Lung Fibrosis as Observed by Sequential Scans of Radiologist Visual Assessment, From Baseline at Weeks 24, 48, and 96 Week 96: Better	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Efficacy: Categorical Changes in Lung Fibrosis as Observed by Sequential Scans of Radiologist Visual Assessment, From Baseline at Weeks 24, 48, and 96 Week 96: Worse	3 Participants	1 Participants	3 Participants	—	4 Participants
Efficacy: Categorical Changes in Lung Fibrosis as Observed by Sequential Scans of Radiologist Visual Assessment, From Baseline at Weeks 24, 48, and 96 Week 96: Same	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 96 Weeks (Weeks 24, 48, and 96)

Population: All randomized subjects

The change in Data-driven Texture Analysis (DTA) Lung Fibrosis mean score using sequential scans from Radiologist's Visual Reads from baseline to Weeks 24, 48, and 96. The change in DTA Lung Fibrosis mean score was measured using sequential scans from Radiologist's Visual Reads from baseline at Weeks 24, 48, and 96. DTA fibrosis score was computed as the number of Region of Interests (ROIs) classified as fibrotic divided by the total number of ROIs sampled from the lung segmentation volume. The DTA fibrosis score ranged from 0 - 100%, where higher scores indicated worsening of disease.

Outcome measures

Measure	Belumosudil-R n=52 Participants Subjects randomized to treatment with belumosudil 400 mg orally (PO) once daily 9QD)	BSC-R n=24 Participants Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	Belumosudil-WC n=69 Participants Subjects randomized to treatment with belumosudil 400 mg PO QD plus subjects randomized to treatment with BSC but cross over to treatment with belumosudil 400 mg PO QD	BSC-NC n=24 Participants Subjects randomized to treatment with BSC and who cross over to treatment with belumosudil 400 mg PO QD but have data censored by the date of crossover	Total n=76 Participants Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Efficacy: Changes in Mean DTA Lung Fibrosis Score, by Radiologist Visual Assessment, From Baseline at Weeks 24, 48, and 96 Baseline	23.1 units on a scale (0-100) Standard Deviation 11.99	22.7 units on a scale (0-100) Standard Deviation 10.77	22.3 units on a scale (0-100) Standard Deviation 12.07	22.7 units on a scale (0-100) Standard Deviation 10.77	22.5 units on a scale (0-100) Standard Deviation 11.35
Efficacy: Changes in Mean DTA Lung Fibrosis Score, by Radiologist Visual Assessment, From Baseline at Weeks 24, 48, and 96 Change at Week 24	0.3 units on a scale (0-100) Standard Deviation 4.82	0.6 units on a scale (0-100) Standard Deviation 4.29	1.2 units on a scale (0-100) Standard Deviation 6.86	0.6 units on a scale (0-100) Standard Deviation 4.43	0.9 units on a scale (0-100) Standard Deviation 5.70
Efficacy: Changes in Mean DTA Lung Fibrosis Score, by Radiologist Visual Assessment, From Baseline at Weeks 24, 48, and 96 Change at Week 48	3.1 units on a scale (0-100) Standard Deviation 7.51	2.9 units on a scale (0-100) Standard Deviation 4.88	2.9 units on a scale (0-100) Standard Deviation 7.26	—	2.9 units on a scale (0-100) Standard Deviation 6.44
Efficacy: Changes in Mean DTA Lung Fibrosis Score, by Radiologist Visual Assessment, From Baseline at Weeks 24, 48, and 96 Change at Week 96	7.5 units on a scale (0-100) Standard Deviation 9.57	5.0 units on a scale (0-100) Standard Deviation 7.07	7.5 units on a scale (0-100) Standard Deviation 9.57	—	6.7 units on a scale (0-100) Standard Deviation 8.16

SECONDARY outcome

Timeframe: Up to 96 weeks (Weeks 24, 48, and 96)

Population: The Modified Intent-to-Treat (mITT) Population was used which consisted of all subjects in the Safety Population who had an evaluable baseline and ≥ 1 evaluable post baseline assessment.

Acute exacerbation of IPF was defined by the following symptoms within 1 month that could not be explained by other reasons: (1) aggravated dyspnea; (2) newly discovered chest interstitial lung abnormality (by radiograph or HRCT); (3) SpO2 decrease to < 88%.

Acute exacerbation was diagnosed if Items #1 and #2 were present or if Items #1 and #3 were present and the following AEs did not occur: (A) any AE with the Preferred Term containing the word "infection" or "cardiac failure"; (B) pulmonary embolism; (C) pneumothorax.

Outcome measures

Measure	Belumosudil-R n=46 Participants Subjects randomized to treatment with belumosudil 400 mg orally (PO) once daily 9QD)	BSC-R n=58 Participants Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	Belumosudil-WC n=21 Participants Subjects randomized to treatment with belumosudil 400 mg PO QD plus subjects randomized to treatment with BSC but cross over to treatment with belumosudil 400 mg PO QD	BSC-NC Subjects randomized to treatment with BSC and who cross over to treatment with belumosudil 400 mg PO QD but have data censored by the date of crossover	Total Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Efficacy: Event-free Probability of Acute Exacerbation of IPF 24 weeks	0.91 Event-free Probability Interval 0.78 to 0.97	0.91 Event-free Probability Interval 0.8 to 0.96	0.92 Event-free Probability Interval 0.54 to 0.99	—	—
Efficacy: Event-free Probability of Acute Exacerbation of IPF 48 weeks	0.85 Event-free Probability Interval 0.7 to 0.93	0.84 Event-free Probability Interval 0.7 to 0.92	—	—	—
Efficacy: Event-free Probability of Acute Exacerbation of IPF 96 weeks	0.64 Event-free Probability Interval 0.44 to 0.78	0.66 Event-free Probability Interval 0.48 to 0.79	—	—	—

SECONDARY outcome

Timeframe: Up to 96 weeks (Weeks 24, 48, and 96)

Population: The Modified Intent-to-Treat (mITT) Population was used which consisted of all subjects in the Safety Population who had an evaluable baseline and ≥ 1 evaluable post baseline assessment.

Progression of IPF exacerbation was defined as the probability of a subject exhibiting IPF time from baseline to any of the following: (1) probability of first respiratory-related hospitalization; (2) probability of respiratory-related death; absolute decline in FVC% Predicted value of ≥ 10% vs. FVC %; probability of predicted value recorded at baseline; and (4) probability of absolute decline in DLCO, adjusted for hemoglobin (Hb), Percent of predicted value of ≥ 15% vs. DLCO at baseline. Subjects randomized to and received BSC were censored on crossover.

Outcome measures

Measure	Belumosudil-R n=46 Participants Subjects randomized to treatment with belumosudil 400 mg orally (PO) once daily 9QD)	BSC-R n=58 Participants Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	Belumosudil-WC n=21 Participants Subjects randomized to treatment with belumosudil 400 mg PO QD plus subjects randomized to treatment with BSC but cross over to treatment with belumosudil 400 mg PO QD	BSC-NC Subjects randomized to treatment with BSC and who cross over to treatment with belumosudil 400 mg PO QD but have data censored by the date of crossover	Total Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Efficacy: Event-free Probability of Progression of IPF 24 weeks	0.86 Event-free Probability Interval 0.71 to 0.93	0.80 Event-free Probability Interval 0.67 to 0.88	0.66 Event-free Probability Interval 0.39 to 0.83	—	—
Efficacy: Event-free Probability of Progression of IPF 48 weeks	0.52 Event-free Probability Interval 0.35 to 0.66	0.47 Event-free Probability Interval 0.33 to 0.6	—	—	—
Efficacy: Event-free Probability of Progression of IPF 96 weeks	0.20 Event-free Probability Interval 0.09 to 0.35	0.16 Event-free Probability Interval 0.07 to 0.28	—	—	—

SECONDARY outcome

Timeframe: Up to 96 weeks (Weeks 24, 48, and 96)

Population: Analysis was of the Modified Intent-to-Treat (mITT) Population, defined as consisting of all subjects in the Safety Population who had an evaluable baseline and ≥ 1 evaluable post-baseline assessment.

Probability of first-related hospitalization defined as any AE where the high-level group term contained the terms "respiratory" and the AE resulted in a hospitalization. Subjects randomized and received BSC were censored on crossover.

Note: The hazard ratios for Belumosudil-R vs. BSC-NC and for Belumosudil-WC vs. BSC-NC were not calculable.

Outcome measures

Measure	Belumosudil-R n=46 Participants Subjects randomized to treatment with belumosudil 400 mg orally (PO) once daily 9QD)	BSC-R n=58 Participants Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	Belumosudil-WC Subjects randomized to treatment with belumosudil 400 mg PO QD plus subjects randomized to treatment with BSC but cross over to treatment with belumosudil 400 mg PO QD	BSC-NC Subjects randomized to treatment with BSC and who cross over to treatment with belumosudil 400 mg PO QD but have data censored by the date of crossover	Total Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Efficacy: Event-free Probability of First Respiratory-related Hospitalization 24 weeks	0.98 Event-free Probability Interval 0.85 to 1.0	0.96 Event-free Probability Interval 0.86 to 0.99	—	—	—
Efficacy: Event-free Probability of First Respiratory-related Hospitalization 96 weeks	0.79 Event-free Probability Interval 0.61 to 0.9	0.75 Event-free Probability Interval 0.58 to 0.85	—	—	—
Efficacy: Event-free Probability of First Respiratory-related Hospitalization 48 weeks	0.89 Event-free Probability Interval 0.74 to 0.96	0.85 Event-free Probability Interval 0.72 to 0.93	—	—	—

SECONDARY outcome

Timeframe: Up to 96 weeks (Weeks 24, 48, and 96)

Population: Analysis was of the Modified Intent-to-Treat (mITT) Population, defined as consisting of all subjects in the Safety Population who had an evaluable baseline and ≥ 1 evaluable post-baseline assessment.

Probability of respiratory-related death, defined as any AE where the high-level group term contained the term "respiratory" and the AE resulted in a death.

Subjects randomized to and who received BSC were censored on crossover.

Outcome measures

Measure	Belumosudil-R n=46 Participants Subjects randomized to treatment with belumosudil 400 mg orally (PO) once daily 9QD)	BSC-R n=58 Participants Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	Belumosudil-WC n=21 Participants Subjects randomized to treatment with belumosudil 400 mg PO QD plus subjects randomized to treatment with BSC but cross over to treatment with belumosudil 400 mg PO QD	BSC-NC Subjects randomized to treatment with BSC and who cross over to treatment with belumosudil 400 mg PO QD but have data censored by the date of crossover	Total Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Efficacy: Event-free Probability of Respiratory-related Death 24 weeks	0.98 Event-free Probability Interval 0.85 to 1.0	0.98 Event-free Probability Interval 0.87 to 1.0	0.95 Event-free Probability Interval 0.69 to 0.99	—	—
Efficacy: Event-free Probability of Respiratory-related Death 48 weeks	0.92 Event-free Probability Interval 0.76 to 0.97	0.91 Event-free Probability Interval 0.77 to 0.97	—	—	—
Efficacy: Event-free Probability of Respiratory-related Death 96 weeks	0.88 Event-free Probability Interval 0.71 to 0.95	0.88 Event-free Probability Interval 0.72 to 0.95	—	—	—

SECONDARY outcome

Timeframe: Up to 96 weeks (Weeks 24, 48, and 96)

Population: All randomized subjects

The St. George's Respiratory Questionnaire (SGRQ) is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in subjects with obstructive airways disease consisting of 2 parts: (1) symptoms component (frequency & severity) with a 3-month recall; and (2) activities that cause or are limited by breathlessness. Impact components (social functioning, psychological disturbances resulting from airways disease) refer to current state as the recall.

Changes were assessed from baseline at Week 24, at Week 48, and at Week 96.

The SGRQ scores range from 0 to 100, with higher scores indicating greater limitations. Based on empirical data and interviews with subjects, a mean change score of 4 units is associated with slightly efficacious treatment, 8 units for moderately efficacious change, and 12 units for very efficacious treatment

Outcome measures

Measure	Belumosudil-R n=52 Participants Subjects randomized to treatment with belumosudil 400 mg orally (PO) once daily 9QD)	BSC-R n=24 Participants Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	Belumosudil-WC n=69 Participants Subjects randomized to treatment with belumosudil 400 mg PO QD plus subjects randomized to treatment with BSC but cross over to treatment with belumosudil 400 mg PO QD	BSC-NC n=24 Participants Subjects randomized to treatment with BSC and who cross over to treatment with belumosudil 400 mg PO QD but have data censored by the date of crossover	Total n=76 Participants Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Efficacy: Mean Changes in SGRQ From Baseline at Weeks 24, 48 and 96 Baseline	64.45 units on a scale Standard Deviation 18.98	74.45 units on a scale Standard Deviation 18.94	64.86 units on a scale Standard Deviation 18.29	74.45 units on a scale Standard Deviation 18.94	68.63 units on a scale Standard Deviation 18.83
Efficacy: Mean Changes in SGRQ From Baseline at Weeks 24, 48 and 96 Change at Week 48	0.36 units on a scale Standard Deviation 15.34	2.07 units on a scale Standard Deviation 9.90	0.41 units on a scale Standard Deviation 14.63	—	0.63 units on a scale Standard Deviation 13.93
Efficacy: Mean Changes in SGRQ From Baseline at Weeks 24, 48 and 96 Change at Week 96	1.50 units on a scale Standard Deviation 16.61	9.35 units on a scale Standard Deviation 4.54	1.37 units on a scale Standard Deviation 15.76	—	2.60 units on a scale Standard Deviation 14.75
Efficacy: Mean Changes in SGRQ From Baseline at Weeks 24, 48 and 96 Change at Week 24	-5.78 units on a scale Standard Deviation 17.74	-2.64 units on a scale Standard Deviation 9.59	-2.63 units on a scale Standard Deviation 18.38	-2.64 units on a scale Standard Deviation 9.59	-2.64 units on a scale Standard Deviation 14.79

Adverse Events

Belumosudil-R

Serious events: 29 serious events

Other events: 50 other events

Deaths: 7 deaths

BSC-R

Serious events: 10 serious events

Other events: 23 other events

Deaths: 3 deaths

Belumosudil-WC

Serious events: 38 serious events

Other events: 67 other events

Deaths: 9 deaths

BSC-NC

Serious events: 4 serious events

Other events: 19 other events

Deaths: 1 deaths

Total

Serious events: 39 serious events

Other events: 73 other events

Deaths: 10 deaths

Serious adverse events

Measure	Belumosudil-R n=51 participants at risk Subjects randomized to treatment with belumosudil 400 mg orally once daily.	BSC-R n=24 participants at risk Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	Belumosudil-WC n=68 participants at risk Subjects randomized to treatment with belumosudil 400 mg PO QD plus subjects randomized to treatment with BSC but cross over to treatment with belumosudil 400 mg PO QD	BSC-NC n=24 participants at risk Subjects randomized to treatment with BSC and who cross over to treatment with belumosudil 400 mg PO QD but have data censored by the date of crossover	Total n=75 participants at risk Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	11.8% 6/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	12.5% 3/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	11.8% 8/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	12.0% 9/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Respiratory, thoracic and mediastinal disorders Dyspnea	9.8% 5/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	8.8% 6/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	8.0% 6/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Respiratory, thoracic and mediastinal disorders Pulmonary edema	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.00% 0/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Cardiac disorders Congestive cardiac failure	5.9% 3/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.4% 3/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.0% 3/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Cardiac disorders Acute left ventricular failure	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Cardiac disorders Acute myocardial infarction (AMI)	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	8.3% 2/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.0% 3/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Cardiac disorders Anginal equivalent	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Cardiac disorders Aortic valve stenosis	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Cardiac disorders Atrial fibrillation	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	8.3% 2/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.4% 3/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.0% 3/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Cardiac disorders Complete atrioventricular block	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Cardiac disorders Bradycardia	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Cardiac disorders Cardiac arrest	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Cardiac disorders Cardiomyopathy	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Cardiac disorders Coronary artery disease	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Cardiac disorders Coronary artery stenosis	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Cardiac disorders Pericarditis	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Cardiac disorders Supraventricular tachycardia	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Cardiac disorders Angina pectoris	0.00% 0/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Cardiac disorders Angina unstable	0.00% 0/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Cardiac disorders Myocardial infarction (MI)	0.00% 0/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Infections and infestations Pneumonia	7.8% 4/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	5.9% 4/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	5.3% 4/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Infections and infestations Corona virus infection	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Infections and infestations Cystitis	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Infections and infestations Influenza	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Infections and infestations Osteomyelitis	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Infections and infestations Pneumona influenzal	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Infections and infestations Sepsis	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Infections and infestations Urosepsis	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Infections and infestations Cellulitis	0.00% 0/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Infections and infestations Localized infection	0.00% 0/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Infections and infestations Viral pneumonia	0.00% 0/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
General disorders Chest pain	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
General disorders Chills	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
General disorders Non-cardiac chest pain	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
General disorders Pyrexia	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Gastrointestinal disorders Abdominal pain	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Gastrointestinal disorders Colitis	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Gastrointestinal disorders Melena	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Gastrointestinal disorders Small intestinal obstruction	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Gastrointestinal disorders Retroperitoneal hemorrhage	0.00% 0/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Nervous system disorders Basal ganglia hemorrhage	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Nervous system disorders Cerebrovascular accident	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Nervous system disorders Dizziness	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Nervous system disorders Transient ischemic attack (TIA)	0.00% 0/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Investigations Troponin increased	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Investigations Abnormal urine analysis	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic lung cancer	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Renal and urinary disorders Acute kidney injury	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Renal and urinary disorders Glomerulonephritis	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Renal and urinary disorders Micturition urgency	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Renal and urinary disorders Renal failure	0.00% 0/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Vascular disorders Deep vein thrombosis	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Vascular disorders Hypotension	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Vascular disorders Superficial thrombophlebitis	0.00% 0/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Injury, poisoning and procedural complications Humerus fracture	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Injury, poisoning and procedural complications Joint dislocation	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Metabolism and nutrition disorders Hypovolemia	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Metabolism and nutrition disorders Dehydration	0.00% 0/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Metabolism and nutrition disorders Hyponatremia	0.00% 0/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Musculoskeletal and connective tissue disorders Musculoskeletal pain	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Musculoskeletal and connective tissue disorders Neck pain	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Skin and subcutaneous tissue disorders Skin ulcer	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Surgical and medical procedures Toe amputation	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Surgical and medical procedures Lung transplant	0.00% 0/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Eye disorders Amaurosis fugax	0.00% 0/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.3% 1/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD

Other adverse events

Measure	Belumosudil-R n=51 participants at risk Subjects randomized to treatment with belumosudil 400 mg orally once daily.	BSC-R n=24 participants at risk Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	Belumosudil-WC n=68 participants at risk Subjects randomized to treatment with belumosudil 400 mg PO QD plus subjects randomized to treatment with BSC but cross over to treatment with belumosudil 400 mg PO QD	BSC-NC n=24 participants at risk Subjects randomized to treatment with BSC and who cross over to treatment with belumosudil 400 mg PO QD but have data censored by the date of crossover	Total n=75 participants at risk Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Musculoskeletal and connective tissue disorders Costcochondritis	5.9% 3/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.4% 3/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.0% 3/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Respiratory, thoracic and mediastinal disorders Dyspnea	37.3% 19/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	20.8% 5/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	30.9% 21/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	16.7% 4/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	32.0% 24/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Respiratory, thoracic and mediastinal disorders Cough	27.5% 14/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	33.3% 8/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	20.6% 14/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	33.3% 8/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	29.3% 22/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	11.8% 6/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	12.5% 3/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	11.8% 8/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	12.0% 9/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Respiratory, thoracic and mediastinal disorders Exertional dyspnea	5.9% 3/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.4% 3/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	5.3% 4/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Respiratory, thoracic and mediastinal disorders Productive cough	5.9% 3/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	8.3% 2/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	5.9% 4/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	8.3% 2/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	6.7% 5/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Respiratory, thoracic and mediastinal disorders Pulmonary mass	5.9% 3/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	8.3% 2/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	7.4% 5/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	6.7% 5/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Respiratory, thoracic and mediastinal disorders Pulmonary edema	5.9% 3/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.4% 3/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.0% 3/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Respiratory, thoracic and mediastinal disorders Epistaxis	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.4% 3/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.0% 3/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Respiratory, thoracic and mediastinal disorders Rales	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Respiratory, thoracic and mediastinal disorders Upper airway cough syndrome	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.4% 3/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.0% 3/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Respiratory, thoracic and mediastinal disorders Lower respiratory tract congestion	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	8.3% 2/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.0% 3/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Respiratory, thoracic and mediastinal disorders Pleuritic pain	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Respiratory, thoracic and mediastinal disorders Sputum discolored	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Respiratory, thoracic and mediastinal disorders Throat irritation	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Respiratory, thoracic and mediastinal disorders Wheezing	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Infections and infestations Viral upper respiratory tract infection	15.7% 8/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	20.8% 5/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	16.2% 11/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	8.3% 2/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	17.3% 13/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Infections and infestations Bronchitis	13.7% 7/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	20.8% 5/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	10.3% 7/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	20.8% 5/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	16.0% 12/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Infections and infestations Pneumonia	13.7% 7/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	10.3% 7/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	9.3% 7/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Infections and infestations Upper respiratory tract infection	9.8% 5/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	25.0% 6/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	11.8% 8/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	16.7% 4/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	14.7% 11/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Infections and infestations Viral gastroenteritis	7.8% 4/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	5.9% 4/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	5.3% 4/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Infections and infestations Sinusitis	5.9% 3/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.4% 3/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.0% 3/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Infections and infestations Tooth infection	5.9% 3/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.4% 3/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.0% 3/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Infections and infestations Cellulitis	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	8.3% 2/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	5.9% 4/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	5.3% 4/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Infections and infestations Corona virus infection	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Infections and infestations Influenza	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.4% 3/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.0% 3/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Infections and infestations Rhinitis	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.4% 3/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.0% 3/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Infections and infestations Urinary tract infection	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.0% 3/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Infections and infestations Viral infection	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Gastrointestinal disorders Diarrhea	23.5% 12/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	25.0% 6/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	26.5% 18/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	24.0% 18/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Gastrointestinal disorders Nausea	11.8% 6/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	16.7% 4/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	11.8% 8/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	12.5% 3/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	13.3% 10/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Gastrointestinal disorders Upper abdominal pain	5.9% 3/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	5.9% 4/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	5.3% 4/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Gastrointestinal disorders Constipation	5.9% 3/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	5.9% 4/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	5.3% 4/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Gastrointestinal disorders Abdominal discomfort	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Gastrointestinal disorders Hiatus hernia	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Gastrointestinal disorders Vomiting	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.4% 3/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.0% 3/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Gastrointestinal disorders Dysphagia	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Gastrointestinal disorders Gastroesophageal reflux disease (GERD)	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Gastrointestinal disorders Inguinal hernia	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Investigations Alanine aminotransferase (ALT) increased	15.7% 8/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	12.5% 3/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	14.7% 10/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	14.7% 11/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Investigations Aspartate aminotransferase (AST) increased	11.8% 6/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	8.3% 2/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	11.8% 8/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	10.7% 8/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Investigations Gamma-glutamyltransferase (GGT) increased	9.8% 5/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	12.5% 3/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	8.8% 6/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	8.3% 2/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	10.7% 8/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Investigations Blood creatinine increased	5.9% 3/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.4% 3/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	5.3% 4/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Investigations Prothrombin time prolonged	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Investigations Weight decreased	5.9% 3/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.4% 3/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.0% 3/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Investigations Weight increased	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Investigations Blood glucose increased	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Investigations Blood lactate dehydrogenase (LDH) increased	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Investigations Blood thyroid stimulating hormone (TSH) increased	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	12.5% 3/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.4% 3/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	5.3% 4/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Investigations Blood urea increased	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Investigations Hepatic enzyme increased	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	8.3% 2/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.4% 3/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.0% 3/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Investigations Electrocardiogram (ECG) ST-segment abnormal	0.00% 0/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	8.3% 2/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Investigations ECG T-wave abnormal	0.00% 0/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	8.3% 2/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
General disorders Fatigue	13.7% 7/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	16.7% 4/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	16.2% 11/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	14.7% 11/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
General disorders Peripheral edema	9.8% 5/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	8.8% 6/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	8.0% 6/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
General disorders Chills	7.8% 4/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	5.9% 4/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	5.3% 4/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
General disorders Catheter site pain	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
General disorders Non-cardiac chest pain	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	8.3% 2/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	8.3% 2/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	5.3% 4/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
General disorders Pyrexia	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
General disorders Pain	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Musculoskeletal and connective tissue disorders Back pain	9.8% 5/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	16.7% 4/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	10.3% 7/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	8.3% 2/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	12.0% 9/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Musculoskeletal and connective tissue disorders Arthralgia	7.8% 4/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	5.9% 4/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	5.3% 4/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Musculoskeletal and connective tissue disorders Muscle spasms	7.8% 4/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	12.5% 3/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	7.4% 5/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	8.3% 2/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	9.3% 7/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.9% 3/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.4% 3/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	5.3% 4/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Musculoskeletal and connective tissue disorders Clubbing	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Musculoskeletal and connective tissue disorders Joint swelling	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Musculoskeletal and connective tissue disorders Neck pain	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Musculoskeletal and connective tissue disorders Pain in extremity	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Musculoskeletal and connective tissue disorders Flank pain	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Musculoskeletal and connective tissue disorders Muscular weakness	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	8.3% 2/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.4% 3/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.0% 3/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Nervous system disorders Dizziness	11.8% 6/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	8.3% 2/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	10.3% 7/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	10.7% 8/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Nervous system disorders Headache	7.8% 4/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	5.9% 4/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	6.7% 5/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Nervous system disorders Memory impairment	7.8% 4/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	5.9% 4/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	5.3% 4/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Nervous system disorders Hypoesthesia	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Nervous system disorders Lethargy	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Nervous system disorders Paresthesia	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.4% 3/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.0% 3/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Nervous system disorders Balance disorder	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Cardiac disorders Supraventricular tachycardia	7.8% 4/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	7.4% 5/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	6.7% 5/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Cardiac disorders Atrial fibrillation	5.9% 3/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	8.3% 2/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	7.4% 5/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	6.7% 5/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Cardiac disorders Congestive cardiac failure	5.9% 3/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	5.9% 4/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	5.3% 4/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Cardiac disorders Coronary artery disease	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	8.3% 2/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	5.9% 4/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	5.3% 4/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Cardiac disorders Acute myocardial infarction (AMI)	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	8.3% 2/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.0% 3/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Cardiac disorders Angina pectoris	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Injury, poisoning and procedural complications Fall	7.8% 4/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	5.9% 4/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	6.7% 5/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Injury, poisoning and procedural complications Stress fracture	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Injury, poisoning and procedural complications Head injuries	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Injury, poisoning and procedural complications Joint injury	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Injury, poisoning and procedural complications Limb injury	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Injury, poisoning and procedural complications Muscle strain	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Injury, poisoning and procedural complications Tooth fracture	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Psychiatric disorders Anxiety	11.8% 6/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	10.3% 7/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	9.3% 7/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Psychiatric disorders Insomnia	7.8% 4/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	7.4% 5/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	6.7% 5/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Psychiatric disorders Depression	5.9% 3/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.4% 3/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.0% 3/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Psychiatric disorders Panic attack	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Metabolism and nutrition disorders Decreased appetite	9.8% 5/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	7.4% 5/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	6.7% 5/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Metabolism and nutrition disorders Hyperglycemia	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.4% 3/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.0% 3/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Metabolism and nutrition disorders Dehydration	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Metabolism and nutrition disorders Hyponatremia	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Metabolism and nutrition disorders Type 2 diabetes mellitus	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Skin and subcutaneous tissue disorders Dermal cyst	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Skin and subcutaneous tissue disorders Erythema	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Skin and subcutaneous tissue disorders Pruritus	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.4% 3/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.0% 3/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Skin and subcutaneous tissue disorders Rash	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	12.5% 3/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.0% 3/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Blood and lymphatic system disorders Leukocytosis	5.9% 3/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.4% 3/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.0% 3/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Blood and lymphatic system disorders Anemia	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.0% 3/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Blood and lymphatic system disorders Thrombocytopenia	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	5.9% 3/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.4% 3/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.0% 3/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Vascular disorders Hypertension	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Vascular disorders Hypotension	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.4% 3/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.0% 3/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Renal and urinary disorders Hematuria	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Ear and labyrinth disorders Vertigo	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Ear and labyrinth disorders Ear pain	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Ear and labyrinth disorders Tinnitus	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Eye disorders Vision blurred	3.9% 2/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Endocrine disorders Hypothyroidism	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
General disorders Small intestinal obstruction	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.9% 2/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	0.00% 0/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Nervous system disorders Syncope	2.0% 1/51 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	1.5% 1/68 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	4.2% 1/24 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD	2.7% 2/75 • Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD

Additional Information

Karin Herrera, Vice President, Clinical Operations

Kadmon Corporation

Phone: 1-724-778-6134

Email: karin.herrera@kadmon.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place