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

• ClinicalTrials.gov Identifier: NCT02688647
• Recruitment Status: Completed
• First Posted: February 23, 2016
• Results First Posted: September 8, 2022
• Last Update Posted: September 8, 2022
• Sponsor: Kadmon Corporation, LLC
• Information provided by (Responsible Party): Kadmon Corporation, LLC

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: Belumosudil; Other: BSC
• Enrollment: 76

Participant Flow

Recruitment Details

Pre-assignment Details

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.

Arm/Group Title	Belumosudil-R	BSC-R
Arm/Group Description	Subjects randomized to treatment with belumosudil 400 mg orally (PO) once daily 9QD).	Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.
Period Title: Initial Treatment Period (24 Weeks)
Started	52	24
Treated	51 [1]	24
Completed	51	18
Not Completed	1	6
Reason Not Completed
Death	0	1
Cross-overed before Initial Treatment Period (24 Weeks)	0	5
Subject was randomized but did not receive treatment	1	0
[1] 1 subject was randomized but did not receive treatment.
Period Title: Post Switch Treatment Period (72 Weeks)
Started	51 [1]	17 [2]
Completed	23	3
Not Completed	28	14
Reason Not Completed
Death	7	2
Lost to Follow-up	1	0
Other	10	6
Withdrawal by Subject	10	6
[1] 51 subjects originally randomized to treatment with belumosudil 400 mg PO QD continued receiving belumosudil 400 mg PO QD.; [2] 17 subjects randomized to treatment with BSC-R cross-overed to treatment with belumosudil 400 mg PO QD.

Baseline Characteristics

Arm/Group Title		Belumosudil 400 mg PO QD	BSC-R	Total
Arm/Group Description		Randomized to treatment with belumosudil 400 mg (two 200-mg tablets) orally once daily.	Subjects randomized to treatment with best supportive care for 24 weeks.	Total of all reporting groups
Overall Number of Baseline Participants		51	24	75
Baseline Analysis Population Description		One subject randomized to belumosudil 400 mg PO QD did not receive study medication. Analysis was performed using the safety population that consisted of all subjects who were randomized and received ≥ 1 dose of belumosudil-R or, for subjects who had BSC, week 1 assessments. Available data at baseline have been reported.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	51 participants	24 participants	75 participants
		72.5 (7.0)	74.9 (5.9)	73.3 (6.7)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	51 participants	24 participants	75 participants
	Female	13 25.5%	6 25.0%	19 25.3%
	Male	38 74.5%	18 75.0%	56 74.7%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	51 participants	24 participants	75 participants
	Hispanic or Latino	6 11.8%	0 0.0%	6 8.0%
	Not Hispanic or Latino	45 88.2%	24 100.0%	69 92.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	51 participants	24 participants	75 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	2 3.9%	0 0.0%	2 2.7%
	White	49 96.1%	24 100.0%	73 97.3%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Prior Use of Pirfenidone; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	51 participants	24 participants	75 participants
Yes		13 25.5%	4 16.7%	17 22.7%
No		38 74.5%	20 83.3%	58 77.3%
Prior Use of Nintedanib; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	51 participants	24 participants	75 participants
Yes		10 19.6%	4 16.7%	14 18.7%
No		41 80.4%	20 83.3%	61 81.3%
Prior Use of Pirfenidone or Nintedanib; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	51 participants	24 participants	75 participants
Yes		19 37.3%	6 25.0%	25 33.3%
No		32 62.7%	18 75.0%	50 66.7%
GAP Stage [1]; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	51 participants	24 participants	75 participants
Stage I		11 21.6%	7 29.2%	18 24.0%
Stage II		31 60.8%	12 50.0%	43 57.3%
Stage III		9 17.6%	5 20.8%	14 18.7%
		[1] Measure Description: GAP = Gender/Age/Physiology. Stage based on total points. G: Gender Points: female = 0 points; male = 1 points A: Age Points: ≤ 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% Predicted: > 55% = 0 points; 36-55% = 1 point; ≤ 35% = 2 points; cannot perform = 3 points STAGE Stage I Index: 0 to 3 points Stage II Index: 4 to 5 points Stage III Index: 6 to 8 points
Presence of Aggravated Dyspnea Within 6 Months Prior to Informed Consent; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	51 participants	24 participants	75 participants
Yes		18 35.3%	11 45.8%	29 38.7%
No		33 64.7%	13 54.2%	46 61.3%
Presence of Chest Interstitial Lung Abnormalities Within 6 Months Prior to Informed Consent; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	51 participants	24 participants	75 participants
Yes		23 45.1%	11 45.8%	34 45.3%
No		28 54.9%	13 54.2%	41 54.7%
SpO2 < 88% Within 6 Months Prior to Informed Consent; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	51 participants	24 participants	75 participants
Yes		7 13.7%	4 16.7%	11 14.7%
No		44 86.3%	20 83.3%	64 85.3%

Outcome Measures

1. Primary Outcome

Title	Efficacy: Mean Changes in FVC From Baseline to Week 24
Description	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
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Belumosudil-R	BSC-R	Belumosudil-WC	BSC-NC	Total
Arm/Group Description:		Subjects randomized to treatment with belumosudil 400 mg orally (PO) once daily 9QD)	Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	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	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	Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Overall Number of Participants Analyzed		52	24	69	24	76
Mean (Standard Deviation); Unit of Measure: mL
Baseline	Number Analyzed	52 participants	24 participants	64 participants	24 participants	76 participants
		2608.2 (829.6)	2516.7 (741.8)	2608.8 (840.4)	2516.7 (741.8)	2569.3 (794.3)
At Week 24	Number Analyzed	38 participants	21 participants	46 participants	19 participants	59 participants
		2626.8 (886.9)	2438.1 (757.1)	2617.4 (890.8)	2436.8 (784.5)	2533.7 (832.7)
Change at Week 24	Number Analyzed	38 participants	21 participants	46 participants	19 participants	59 participants
		-115.8 (330.3)	-71.2 (254.2)	-110.8 (316.4)	-103.4 (225.0)	-99.5 (281.4)

2. Primary Outcome

Title	Efficacy: Mean Changes in FVC% Predicted From Baseline at Week 24
Description	Changes in the mean Forced Vital Capacity (FVC)% Predicted from baseline at Week 24. Normal FVC%: 80% to 120%
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Belumosudil-R	BSC-R	Belumosudil-WC	BSC-NC	Total
Arm/Group Description:		Subjects randomized to treatment with belumosudil 400 mg orally once daily.	Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	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	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	Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Overall Number of Participants Analyzed		52	24	69	24	76
Mean (Standard Deviation); Unit of Measure: % of predicted
Baseline	Number Analyzed	52 participants	24 participants	64 participants	24 participants	76 participants
		69.61 (18.07)	68.46 (15.63)	69.73 (17.70)	68.46 (15.63)	69.19 (16.71)
At Week 24	Number Analyzed	38 participants	21 participants	46 participants	19 participants	59 participants
		69.71 (19.20)	68.29 (13.41)	69.96 (18.43)	68.58 (13.98)	69.24 (16.25)
Change at Week 24	Number Analyzed	38 participants	21 participants	46 participants	19 participants	59 participants
		-2.82 (7.57)	-2.00 (7.36)	-2.66 (7.49)	-3.00 (6.41)	-2.58 (7.16)

3. Primary Outcome

Title	Safety: Percentages of Subjects With Non-serious TEAEs and Relationship to Study Treatment
Description	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).
Time Frame	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.

Outcome Measure Data

Analysis Population Description

All subjects treated in study.

Arm/Group Title	Belumosudil-R	BSC-R	Belumosudil-WC	BSC-NC	Total
Arm/Group Description:	Subjects randomized to treatment with belumosudil 400 mg orally once daily.	Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	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	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	Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Overall Number of Participants Analyzed	51	24	68	24	75
Measure Type: Count of Participants; Unit of Measure: Participants
TEAEs Related to Treatment (All Grades)	23 45.1%	9 37.5%	32 47.1%	2 8.3%	32 42.7%
TEAEs Related to Treatment (Only Grades 3 & 4)	2 3.9%	0 0.0%	2 2.9%	0 0.0%	2 2.7%

4. Primary Outcome

Title	Safety: Percentages of Subjects With SAEs Related to Study Treatment
Description	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.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

All subjects treated in study.

Arm/Group Title	Belumosudil-R	BSC-R	Belumosudil-WC	BSC-NC	Total
Arm/Group Description:	Subjects randomized to treatment with belumosudil 400 mg orally once daily.	Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	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	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	Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Overall Number of Participants Analyzed	51	24	68	24	75
Measure Type: Count of Participants; Unit of Measure: Participants
	2 3.9%	0 0.0%	2 2.9%	0 0.0%	2 2.7%

5. Primary Outcome

Title	Safety: Percentages of Subjects With TEAEs Leading to Discontinuation of Treatment With Belumosudil
Description	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.
Time Frame	Up to 96 weeks (Weeks 24, 48, and 96) of treatment with belumosudil

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Belumosudil-R	BSC-R	Belumosudil-WC	Total
Arm/Group Description:	Subjects randomized to treatment with belumosudil 400 mg orally once daily.	Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	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	Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Overall Number of Participants Analyzed	51	24	68	75
Measure Type: Count of Participants; Unit of Measure: Participants
All TEAEs Leading to Discontinuation	14 27.5%	8 33.3%	22 32.4%	22 29.3%
TEAEs Related to Belumosudil Leading to Study Discontinuation	5 9.8%	1 4.2%	6 8.8%	6 8.0%

6. Primary Outcome

Title	Safety: Percentages of Subjects With Deaths Related to Study Treatment
Description	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.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

All subjects treated in study.

Arm/Group Title	Belumosudil-R	BSC-R	Belumosudil-WC	BSC-NC	Total
Arm/Group Description:	Subjects randomized to treatment with belumosudil 400 mg orally once daily.	Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	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	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	Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Overall Number of Participants Analyzed	51	24	68	19	75
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

7. Secondary Outcome

Title	Efficacy: Mean Changes in FVC From Baseline at Week 24 by GAP Stage and by Use of Pirfenidone or Nintedanib--
Description	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
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title		Belumosudil-WC	BSC-NC
Arm/Group Description:		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	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
Overall Number of Participants Analyzed		58	21
Geometric Least Squares Mean (95% Confidence Interval); Unit of Measure: mL
GAP Stage I	Number Analyzed	13 participants	7 participants
		-117.65; (-324.28 to 88.98)	-156.50; (-355.39 to 42.40)
GAP Stage II	Number Analyzed	26 participants	9 participants
		-219.90; (-416.20 to -23.60)	-179.94; (-444.35 to 84.47)
GAP Stage III	Number Analyzed	7 participants	3 participants
		101.95; (-1246.61 to 1450.50)	7.79; (-1553.37 to 1568.95)
No Prior Use of Pirfenidone or Nintedanib	Number Analyzed	34 participants	16 participants
		-80.34; (-190.81 to 30.14)	-46.21; (-167.93 to 75.51)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Belumosudil-WC, BSC-NC
	Comments	GAP Stage I-- Difference: Belumosudil-WC minus BSC-NC = 38.85 (95% CI: -126.99, 204.69) mL
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5733
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Results are not stable due to small sample size and signal/noise ratio

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Belumosudil-WC, BSC-NC
	Comments	GAP Stage II-- Difference: Belumosudil-WC minus BSC-NC = -39.96 (95% CI: -288.63, 208.71) mL
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.6967
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Results are not stable due to small sample size and signal/noise ratio

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Belumosudil-WC, BSC-NC
	Comments	GAP Stage III-- Difference: Belumosudil-WC minus BSC-NC = 94.16 (95% CI: -1103.56, 1291.88) mL
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5003
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Results are not stable due to small sample size and signal/noise ratio

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Belumosudil-WC, BSC-NC
	Comments	No Prior Pirfenidone or Nintedanib-- Difference: Belumosudil-WC minus BSC-NC = -34.13 (95% CI: -137.08, 68.82)
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.4866
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Results are not stable due to small sample size and signal/noise ratio

8. Secondary Outcome

Title	Efficacy: Mean Changes in FVC From Baseline at Week 48, Week 96, and EOT
Description	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
Time Frame	Up to 96 weeks (Weeks 24, 48, and 96)

Outcome Measure Data

Analysis Population Description

All randomized subjects

Arm/Group Title		Belumosudil-R	BSC-R	Belumosudil-WC	Total
Arm/Group Description:		Subjects randomized to treatment with belumosudil 400 mg orally once daily.	Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	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	Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Overall Number of Participants Analyzed		52	24	69	76
Mean (Standard Deviation); Unit of Measure: mL
Baseline	Number Analyzed	52 participants	24 participants	64 participants	76 participants
		2608.2 (829.6)	2516.7 (741.8)	2608.8 (840.4)	2569.3 (794.3)
Change at Week 48	Number Analyzed	29 participants	8 participants	35 participants	37 participants
		-197.2 (331.5)	-82.5 (329.7)	-199.6 (366.1)	-177.8 (358.8)
Change at Week 96	Number Analyzed	20 participants	5 participants	23 participants	25 participants
		-141.0 (401.1)	-264.0 (896.0)	-122.2 (384.3)	-147.5 (492.3)
Change at EOT	Number Analyzed	21 participants	7 participants	27 participants	28 participants
		-227.9 (367.7)	-110.7 (397.7)	-207.2 (353.7)	-180.9 (355.8)

9. Secondary Outcome

Title	Efficacy: Mean Change in Mean FEV1/FVC Ratio From Baseline at Weeks 24, 48, and 96 and EOT
Description	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
Time Frame	Up to 96 weeks (Weeks 24, 48, and 96)

Outcome Measure Data

Analysis Population Description

All randomized subjects

Arm/Group Title		Belumosudil-R	BSC-R	Belumosudil-WC	BSC-NC	Total
Arm/Group Description:		Subjects randomized to treatment with belumosudil 400 mg orally once daily.	Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	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	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	Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Overall Number of Participants Analyzed		52	24	69	24	76
Mean (Standard Deviation); Unit of Measure: Units
Baseline	Number Analyzed	52 participants	24 participants	64 participants	24 participants	76 participants
		0.829 (0.0613)	0.816 (0.0674)	0.832 (0.0584)	0.816 (0.0674)	0.825 (0.0623)
Change at Week 24	Number Analyzed	38 participants	21 participants	46 participants	19 participants	59 participants
		-0.006 (0.0444)	0.013 (0.0310)	-0.005 (0.0410)	0.016 (0.0311)	0.004 (0.0378)
Change at Week 48	Number Analyzed	29 participants	8 participants	35 participants	0 participants	37 participants
		0.001 (0.0251)	-0.005 (0.0141)	-0.001 (0.0249)		-0.002 (0.0232)
Change at Week 96	Number Analyzed	20 participants	5 participants	23 participants	0 participants	25 participants
		-0.012 (0.0420)	-0.014 (0.0378)	-0.012 (0.0402)		-0.012 (0.0391)
Change at EOT	Number Analyzed	21 participants	7 participants	27 participants	1 participants	28 participants
		-0.010 (0.0362)	0.011 (0.0372)	-0.011 (0.0453)	-0.010 (0)	-0.007 (0.0436)

10. Secondary Outcome

Title	Efficacy: Mean Changes in FVC% Predicted at Week 24 by GAP Stage and by Use of Pirfenidone or Nintedanib--
Description	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
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title		Belumosudil-WC	BSC-NC
Arm/Group Description:		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	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
Overall Number of Participants Analyzed		58	21
Geometric Least Squares Mean (95% Confidence Interval); Unit of Measure: % of predicted
GAP Stage I	Number Analyzed	13 participants	7 participants
		-4.65; (-11.34 to 2.03)	-6.53; (-13.14 to 0.07)
GAP Stage II	Number Analyzed	26 participants	9 participants
		-6.42; (-11.69 to -1.15)	-4.69; (-11.58 to 2.19)
GAP Stage III	Number Analyzed	7 participants	3 participants
		2.34; (-36.32 to 40.99)	-0.15; (-42.95 to 42.65)
Prior Use of Pirfenidone or Nintedanib	Number Analyzed	12 participants	3 participants
		-6.20; (-58.23 to 45.82)	-14.91; (-92.49 to 62.68)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Belumosudil-WC, BSC-NC
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	GAP Stage I-- Difference: Belumosudil-WC minus BSC-NC = 1.88 (95% CI: -2.69, 6.45)
Statistical Test of Hypothesis	P-Value	0.3391
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Results are not stable due to small sample size and signal/noise ratio

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Belumosudil-WC, BSC-NC
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	GAP Stage II-- Difference: Belumosudil-WC minus BSC-NC = -1.72 (95% CI: -8.13, 4.69)
Statistical Test of Hypothesis	P-Value	0.5201
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Results are not stable due to small sample size and signal/noise ratio

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Belumosudil-WC, BSC-NC
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	GAP Stage III-- Difference: Belumosudil-WC minus BSC-NC = 2.48 (95% CI: -23.84, 28.81)
Statistical Test of Hypothesis	P-Value	0.4426
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Results are not stable due to small sample size and signal/noise ratio

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Belumosudil-WC, BSC-NC
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	No Prior Use of Pirfenidone or Nintedanib-- Difference: Belumosudil-WC minus BSC-NC = 8.70 (95% CI: -78.76, -96.17)
Statistical Test of Hypothesis	P-Value	0.4260
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Results are not stable due to small sample size and signal/noise ratio

11. Secondary Outcome

Title	Efficacy: Percentages of Subjects With Decrease ≥ 5% in FVC% Predicted From Baseline at Weeks 24, 48, and 96
Description	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
Time Frame	Up to 96 weeks (Weeks 24, 48, and 96)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title		Belumosudil-R	BSC-R	Belumosudil-WC	BSC-NC	Total
Arm/Group Description:		Subjects randomized to treatment with belumosudil 400 mg orally once daily.	Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	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	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	Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Overall Number of Participants Analyzed		46	24	58	21	70
Measure Type: Count of Participants; Unit of Measure: Participants
At Week 24: Yes	Number Analyzed	38 participants	21 participants	46 participants	19 participants	59 participants
		11 28.9%	7 33.3%	14 30.4%	7 36.8%	21 35.6%
At Week 24: No	Number Analyzed	38 participants	21 participants	46 participants	19 participants	59 participants
		27 71.1%	14 66.7%	32 69.6%	12 63.2%	42 71.2%
At Week 48: Yes	Number Analyzed	29 participants	8 participants	35 participants	0 participants	37 participants
		14 48.3%	4 50.0%	16 45.7%		18 48.6%
At Week 48: No	Number Analyzed	29 participants	8 participants	35 participants	0 participants	37 participants
		15 51.7%	4 50.0%	19 54.3%		20 54.1%
At Week 96: Yes	Number Analyzed	20 participants	5 participants	23 participants	0 participants	25 participants
		6 30.0%	2 40.0%	6 26.1%		8 32.0%
At Week 96: No	Number Analyzed	20 participants	5 participants	23 participants	0 participants	25 participants
		14 70.0%	3 60.0%	17 73.9%		17 68.0%

12. Secondary Outcome

Title	Efficacy: Percentage of Subjects With Decrease ≥ 10% in FVC% Predicted at Weeks 24, 48, and 96
Description	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
Time Frame	Up to 96 weeks (Weeks 24, 48, and 96)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title		Belumosudil-R	BSC-R	Belumosudil-WC	BSC-NC	Total
Arm/Group Description:		Subjects randomized to treatment with belumosudil 400 mg orally once daily.	Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	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	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	Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Overall Number of Participants Analyzed		46	24	58	21	70
Measure Type: Count of Participants; Unit of Measure: Participants
At Week 24: Yes	Number Analyzed	38 participants	21 participants	46 participants	19 participants	59 participants
		5 13.2%	4 19.0%	6 13.0%	4 21.1%	10 16.9%
At Week 24: No	Number Analyzed	38 participants	21 participants	46 participants	19 participants	59 participants
		33 86.8%	17 81.0%	40 87.0%	15 78.9%	50 84.7%
At Week 48: Yes	Number Analyzed	29 participants	8 participants	35 participants	0 participants	37 participants
		7 24.1%	1 12.5%	9 25.7%		10 27.0%
At Week 48: No	Number Analyzed	29 participants	8 participants	35 participants	0 participants	37 participants
		22 75.9%	7 87.5%	26 74.3%		30 81.1%
At Week 96: Yes	Number Analyzed	20 participants	5 participants	23 participants	0 participants	25 participants
		5 25.0%	2 40.0%	5 21.7%		7 28.0%
At Week 96: No	Number Analyzed	20 participants	5 participants	23 participants	0 participants	25 participants
		15 75.0%	3 60.0%	18 78.3%		18 72.0%

13. Secondary Outcome

Title	Efficacy: Mean Change in 6MWD at Weeks 24, 48, and 96
Description	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
Time Frame	Up to 96 weeks (Weeks 24, 48, and 96)

Outcome Measure Data

Analysis Population Description

All randomized subjects

Arm/Group Title		Belumosudil-R	BSC-R	Belumosudil-WC	BSC-NC	Total
Arm/Group Description:		Subjects randomized to treatment with belumosudil 400 mg orally once daily.	Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	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	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	Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Overall Number of Participants Analyzed		52	24	69	24	76
Mean (Standard Deviation); Unit of Measure: meters
Baseline	Number Analyzed	51 participants	24 participants	65 participants	19 participants	75 participants
		368.59 (168.84)	349.25 (180.40)	350.12 (168.88)	323.11 (126.64)	345.17 (163.88)
Change at Week 24	Number Analyzed	37 participants	20 participants	45 participants	13 participants	57 participants
		-12.11 (101.78)	-16.60 (66.80)	7.53 (177.88)	-0.77 (49.08)	-0.04 (140.22)
Change at Week 48	Number Analyzed	30 participants	8 participants	36 participants	0 participants	38 participants
		-18.33 (102.45)	119.00 (364.61)	-18.83 (95.33)		6.23 (178.69)
Change at Week 96	Number Analyzed	17 participants	5 participants	20 participants	0 participants	22 participants
		-23.06 (78.84)	-47.80 (69.80)	-20.98 (72.80)		-26.34 (71.60)

14. Secondary Outcome

Title	Efficacy: Percentages of Subjects With ≥ 50 Meter Improvement in 6MWD at Weeks 24, 48, and 96
Description	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.
Time Frame	Up to 96 weeks (Weeks 24, 48, and 96)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title		Belumosudil-R	BSC-R	Belumosudil-WC	BSC-NC	Total
Arm/Group Description:		Subjects randomized to treatment with belumosudil 400 mg orally once daily.	Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	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	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	Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Overall Number of Participants Analyzed		46	24	58	21	70
Measure Type: Count of Participants; Unit of Measure: Participants
≥ 50 Meter Improvement at Week 24: Yes	Number Analyzed	37 participants	20 participants	45 participants	13 participants	57 participants
		6 16.2%	4 20.0%	8 17.8%	2 15.4%	11 19.3%
≥ 50 Meter Improvement at Week 24: No	Number Analyzed	37 participants	20 participants	45 participants	13 participants	70 participants
		31 83.8%	16 80.0%	37 82.2%	11 84.6%	48 68.6%
≥ 50 Meter Improvement at Week 48: Yes	Number Analyzed	30 participants	8 participants	36 participants	0 participants	38 participants
		6 20.0%	2 25.0%	8 22.2%		10 26.3%
≥ 50 Meter Improvement at Week 48: No	Number Analyzed	30 participants	8 participants	36 participants	0 participants	38 participants
		24 80.0%	6 75.0%	28 77.8%		32 84.2%
≥ 50 Meter Improvement at Week 96: Yes	Number Analyzed	17 participants	5 participants	20 participants	0 participants	22 participants
		5 29.4%	2 40.0%	5 25.0%		7 31.8%
≥ 50 Meter Improvement at Week 96: No	Number Analyzed	17 participants	5 participants	20 participants	0 participants	22 participants
		12 70.6%	3 60.0%	15 75.0%		15 68.2%

15. Secondary Outcome

Title	Efficacy: Mean Changes in DLCO (%) at Weeks 24, 48, and 96
Description	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%
Time Frame	Up to 96 weeks (Weeks 24, 48, and 96)

Outcome Measure Data

Analysis Population Description

All randomized subjects

Arm/Group Title		Belumosudil-R	BSC-R	Belumosudil-WC	BSC-NC	Total
Arm/Group Description:		Subjects randomized to treatment with belumosudil 400 mg orally once daily.	Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	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	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	Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Overall Number of Participants Analyzed		52	24	69	24	76
Mean (Standard Deviation); Unit of Measure: % of diffusing capacity of CO
Baseline	Number Analyzed	51 participants	24 participants	63 participants	19 participants	75 participants
		47.3 (11.7)	47.3 (9.9)	47.1 (12.0)	48.0 (10.2)	47.3 (11.1)
Change at Week 24	Number Analyzed	35 participants	21 participants	42 participants	15 participants	56 participants
		-2.7 (9.5)	-3.8 (5.4)	-3.1 (9.3)	-4.5 (5.6)	-3.6 (7.7)
Change at Week 48	Number Analyzed	28 participants	8 participants	34 participants	0 participants	36 participants
		-2.9 (8.3)	-7.1 (12.7)	-3.2 (8.0)		-3.9 (9.0)
Change at Week 96	Number Analyzed	10 participants	5 participants	13 participants	0 participants	15 participants
		-4.2 (11.3)	-13.7 (17.7)	-6.0 (11.4)		-8.2 (13.4)

16. Secondary Outcome

Title	Efficacy: Percentages of Subjects With Change From Baseline in DLCO (%) ≤ -15% at Weeks 24, 48, and 96
Description	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%
Time Frame	Up to 96 weeks (Weeks 24, 48, and 96)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title		Belumosudil-R	BSC-R	Belumosudil-WC	BSC-NC	Total
Arm/Group Description:		Subjects randomized to treatment with belumosudil 400 mg orally once daily.	Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	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	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	Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Overall Number of Participants Analyzed		46	24	58	21	70
Measure Type: Count of Participants; Unit of Measure: Participants
Week 24 Change ≤ -15%: Yes	Number Analyzed	36 participants	21 participants	43 participants	15 participants	57 participants
		7 19.4%	7 33.3%	10 23.3%	6 40.0%	16 28.1%
Week 24 Change ≤ -15%: No	Number Analyzed	36 participants	21 participants	43 participants	15 participants	57 participants
		29 80.6%	14 66.7%	33 76.7%	9 60.0%	43 75.4%
Week 48 Change ≤ -15%: Yes	Number Analyzed	28 participants	8 participants	34 participants	0 participants	36 participants
		10 35.7%	4 50.0%	11 32.4%		14 38.9%
Week 48 Change ≤ -15%: No	Number Analyzed	28 participants	8 participants	34 participants	0 participants	36 participants
		18 64.3%	4 50.0%	23 67.6%		24 66.7%
Week 96 Change ≤ -15%: Yes	Number Analyzed	10 participants	5 participants	13 participants	0 participants	15 participants
		3 30.0%	4 80.0%	5 38.5%		7 46.7%
Week 96 Change ≤ -15%: No	Number Analyzed	10 participants	5 participants	13 participants	0 participants	15 participants
		7 70.0%	1 20.0%	8 61.5%		8 53.3%

17. Secondary Outcome

Title	Efficacy: Mean Changes in Total Lung Fibrosis Score, by HRCT, From Baseline at Weeks 24, 48, and 96
Description	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.
Time Frame	Up to 96 weeks (Weeks 24, 48, and 96)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title		Belumosudil-R	BSC-R	Belumosudil-WC	BSC-NC	Total
Arm/Group Description:		Subjects randomized to treatment with belumosudil 400 mg orally once daily.	Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	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	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	Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Overall Number of Participants Analyzed		52	24	69	24	76
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	43 participants	21 participants	45 participants	21 participants	64 participants
		30.91 (14.54)	33.34 (17.81)	31.78 (15.48)	33.34 (17.81)	32.53 (16.45)
Change at Week 24	Number Analyzed	32 participants	17 participants	34 participants	16 participants	49 participants
		7.36 (11.46)	1.08 (6.31)	8.00 (12.55)	1.41 (6.31)	4.67 (10.44)
Change at Week 48	Number Analyzed	22 participants	7 participants	23 participants	0 participants	29 participants
		6.51 (11.76)	6.23 (13.27)	6.01 (11.74)		6.06 (11.87)
Change at Week 96	Number Analyzed	15 participants	3 participants	15 participants	0 participants	18 participants
		6.36 (10.41)	8.47 (21.86)	6.36 (10.41)		6.71 (12.09)

18. Secondary Outcome

Title	Efficacy: Categorical Changes in Lung Fibrosis as Observed by Sequential Scans of Radiologist Visual Assessment, From Baseline at Weeks 24, 48, and 96
Description	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).
Time Frame	Up to 96 weeks (Weeks 24, 48, and 96)

Outcome Measure Data

Analysis Population Description

All randomized subjects.

Arm/Group Title		Belumosudil-R	BSC-R	Belumosudil-WC	BSC-NC	Total
Arm/Group Description:		Subjects randomized to treatment with belumosudil 400 mg orally once daily.	Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	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	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	Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Overall Number of Participants Analyzed		46	24	58	21	70
Measure Type: Count of Participants; Unit of Measure: Participants
Week 24: Better	Number Analyzed	35 participants	18 participants	43 participants	16 participants	53 participants
		0 0.0%	1 5.6%	1 2.3%	1 6.3%	1 1.9%
Week 24: Same	Number Analyzed	35 participants	18 participants	43 participants	16 participants	53 participants
		22 62.9%	13 72.2%	25 58.1%	11 68.8%	35 66.0%
Week 24: Worse	Number Analyzed	35 participants	18 participants	43 participants	16 participants	53 participants
		13 37.1%	4 22.2%	17 39.5%	4 25.0%	17 32.1%
Week 48: Better	Number Analyzed	16 participants	7 participants	20 participants	0 participants	23 participants
		0 0.0%	1 14.3%	1 5.0%		1 4.3%
Week 48: Same	Number Analyzed	16 participants	7 participants	20 participants	0 participants	23 participants
		6 37.5%	1 14.3%	6 30.0%		7 30.4%
Week 48: Worse	Number Analyzed	16 participants	7 participants	20 participants	0 participants	23 participants
		10 62.5%	5 71.4%	13 65.0%		15 65.2%
Week 96: Better	Number Analyzed	4 participants	2 participants	5 participants	0 participants	6 participants
		0 0.0%	1 50.0%	1 20.0%	0	1 16.7%
Week 96: Same	Number Analyzed	4 participants	2 participants	5 participants	0 participants	6 participants
		1 25.0%	0 0.0%	1 20.0%	0	1 16.7%
Week 96: Worse	Number Analyzed	4 participants	2 participants	5 participants	0 participants	6 participants
		3 75.0%	1 50.0%	3 60.0%		4 66.7%

19. Secondary Outcome

Title	Efficacy: Changes in Mean DTA Lung Fibrosis Score, by Radiologist Visual Assessment, From Baseline at Weeks 24, 48, and 96
Description	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.
Time Frame	Up to 96 Weeks (Weeks 24, 48, and 96)

Outcome Measure Data

Analysis Population Description

All randomized subjects

Arm/Group Title		Belumosudil-R	BSC-R	Belumosudil-WC	BSC-NC	Total
Arm/Group Description:		Subjects randomized to treatment with belumosudil 400 mg orally once daily.	Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	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	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	Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Overall Number of Participants Analyzed		52	24	69	24	76
Mean (Standard Deviation); Unit of Measure: units on a scale (0-100)
Baseline	Number Analyzed	42 participants	22 participants	48 participants	22 participants	65 participants
		23.1 (11.99)	22.7 (10.77)	22.3 (12.07)	22.7 (10.77)	22.5 (11.35)
Change at Week 24	Number Analyzed	31 participants	17 participants	34 participants	16 participants	48 participants
		0.3 (4.82)	0.6 (4.29)	1.2 (6.86)	0.6 (4.43)	0.9 (5.70)
Change at Week 48	Number Analyzed	13 participants	7 participants	14 participants	0 participants	20 participants
		3.1 (7.51)	2.9 (4.88)	2.9 (7.26)		2.9 (6.44)
Change at Week 96	Number Analyzed	4 participants	2 participants	4 participants	0 participants	6 participants
		7.5 (9.57)	5.0 (7.07)	7.5 (9.57)		6.7 (8.16)

20. Secondary Outcome

Title	Efficacy: Event-free Probability of Acute Exacerbation of IPF
Description	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.
Time Frame	Up to 96 weeks (Weeks 24, 48, and 96)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title		Belumosudil-R	Belumosudil-WC	BSC-NC
Arm/Group Description:		Subjects randomized to treatment with belumosudil 400 mg orally once daily.	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	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
Overall Number of Participants Analyzed		46	58	21
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Event-free Probability
24 weeks	Number Analyzed	46 participants	58 participants	21 participants
		0.91; (0.78 to 0.97)	0.91; (0.80 to 0.96)	0.92; (0.54 to 0.99)
48 weeks	Number Analyzed	46 participants	58 participants	0 participants
		0.85; (0.70 to 0.93)	0.84; (0.70 to 0.92)
96 weeks	Number Analyzed	46 participants	58 participants	0 participants
		0.64; (0.44 to 0.78)	0.66; (0.48 to 0.79)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Belumosudil-R, BSC-NC
	Comments	Hazard ratio: 0.86 (0.16, 4.48)
	Type of Statistical Test	Superiority
	Comments	Cox Regression
Statistical Test of Hypothesis	P-Value	0.8561
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Belumosudil-WC, BSC-NC
	Comments	Hazard ratio: 0.87 (95% CI: 0.17, 4.33)
	Type of Statistical Test	Superiority
	Comments	Cox Regression
Statistical Test of Hypothesis	P-Value	0.8608
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

21. Secondary Outcome

Title	Efficacy: Event-free Probability of Progression of IPF
Description	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.
Time Frame	Up to 96 weeks (Weeks 24, 48, and 96)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title		Belumosudil-R	Belumosudil-WC	BSC-NC
Arm/Group Description:		Subjects randomized to treatment with belumosudil 400 mg orally once daily.	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	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
Overall Number of Participants Analyzed		46	58	21
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Event-free Probability
24 weeks	Number Analyzed	46 participants	58 participants	21 participants
		0.86; (0.71 to 0.93)	0.80; (0.67 to 0.88)	0.66; (0.39 to 0.83)
48 weeks	Number Analyzed	46 participants	58 participants	0 participants
		0.52; (0.35 to 0.66)	0.47; (0.33 to 0.60)
96 weeks	Number Analyzed	46 participants	58 participants	0 participants
		0.20; (0.09 to 0.35)	0.16; (0.07 to 0.28)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Belumosudil-R, BSC-NC
	Comments	Hazard ratio: 0.34 (95% CI: 0.14, 0.79)
	Type of Statistical Test	Superiority
	Comments	Cox Regression
Statistical Test of Hypothesis	P-Value	0.0084
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Belumosudil-WC, BSC-NC
	Comments	Hazard Ratio: 0.47 (95% CI: 0.22, 1.03)
	Type of Statistical Test	Superiority
	Comments	Cox Regression
Statistical Test of Hypothesis	P-Value	0.0508
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

22. Secondary Outcome

Title	Efficacy: Event-free Probability of First Respiratory-related Hospitalization
Description	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.
Time Frame	Up to 96 weeks (Weeks 24, 48, and 96)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Belumosudil-R	Belumosudil-WC
Arm/Group Description:	Subjects randomized to treatment with belumosudil 400 mg orally once daily.	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
Overall Number of Participants Analyzed	46	58
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Event-free Probability
24 weeks	0.98; (0.85 to 1.00)	0.96; (0.86 to 0.99)
48 weeks	0.89; (0.74 to 0.96)	0.85; (0.72 to 0.93)
96 weeks	0.79; (0.61 to 0.90)	0.75; (0.58 to 0.85)

23. Secondary Outcome

Title	Efficacy: Event-free Probability of Respiratory-related Death
Description	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.
Time Frame	Up to 96 weeks (Weeks 24, 48, and 96)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title		Belumosudil-R	Belumosudil-WC	BSC-NC
Arm/Group Description:		Subjects randomized to treatment with belumosudil 400 mg orally once daily.	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	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
Overall Number of Participants Analyzed		46	58	21
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Event-free Probability
24 weeks	Number Analyzed	46 participants	58 participants	21 participants
		0.98; (0.85 to 1.00)	0.98; (0.87 to 1.00)	0.95; (0.69 to 0.99)
48 weeks	Number Analyzed	46 participants	58 participants	0 participants
		0.92; (0.76 to 0.97)	0.91; (0.77 to 0.97)
96 weeks	Number Analyzed	46 participants	58 participants	0 participants
		0.88; (0.71 to 0.95)	0.88; (0.72 to 0.95)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Belumosudil-R, BSC-NC
	Comments	Hazard ratio: 0.34 (95% CI: 0.02, 5.54)
	Type of Statistical Test	Superiority
	Comments	Cox Regression
Statistical Test of Hypothesis	P-Value	0.4251
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Belumosudil-WC, BSC-NC
	Comments	Hazard ratio: 0.27 (95% CI: 0.02, 4.45)
	Type of Statistical Test	Superiority
	Comments	Cox Regression
Statistical Test of Hypothesis	P-Value	0.3294
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

24. Secondary Outcome

Title	Efficacy: Mean Changes in SGRQ From Baseline at Weeks 24, 48 and 96
Description	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
Time Frame	Up to 96 weeks (Weeks 24, 48, and 96)

Outcome Measure Data

Analysis Population Description

All randomized subjects

Arm/Group Title		Belumosudil-R	BSC-R	Belumosudil-WC	BSC-NC	Total
Arm/Group Description:		Subjects randomized to treatment with belumosudil 400 mg orally once daily.	Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	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	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	Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Overall Number of Participants Analyzed		52	24	69	24	76
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline	Number Analyzed	27 participants	12 participants	37 participants	12 participants	42 participants
		64.45 (18.98)	74.45 (18.94)	64.86 (18.29)	74.45 (18.94)	68.63 (18.83)
Change at Week 24	Number Analyzed	31 participants	16 participants	39 participants	15 participants	49 participants
		-5.78 (17.74)	-2.64 (9.59)	-2.63 (18.38)	-2.64 (9.59)	-2.64 (14.79)
Change at Week 48	Number Analyzed	17 participants	3 participants	20 participants	0 participants	21 participants
		0.36 (15.34)	2.07 (9.90)	0.41 (14.63)		0.63 (13.93)
Change at Week 96	Number Analyzed	10 participants	2 participants	11 participants	0 participants	13 participants
		1.50 (16.61)	9.35 (4.54)	1.37 (15.76)		2.60 (14.75)

Adverse Events

Time Frame	Subjects randomized to belumosudil 400 mg PO QD: up to 96 weeks of treatment Subjects randomized to BSC: 24 weeks of BSC plus up to 96 weeks of treatment with belumosudil 400 mg PO QD
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Belumosudil-R	BSC-R	Belumosudil-WC	BSC-NC	Total
Arm/Group Description	Subjects randomized to treatment with belumosudil 400 mg orally once daily.	Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.	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	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	Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
All-Cause Mortality
	Belumosudil-R	BSC-R	Belumosudil-WC	BSC-NC	Total
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	7/51 (13.73%)	3/24 (12.50%)	9/68 (13.24%)	1/24 (4.17%)	10/75 (13.33%)
Serious Adverse Events
	Belumosudil-R	BSC-R	Belumosudil-WC	BSC-NC	Total
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	29/51 (56.86%)	10/24 (41.67%)	38/68 (55.88%)	4/24 (16.67%)	39/75 (52.00%)
Cardiac disorders
Congestive cardiac failure † 1	3/51 (5.88%)	0/24 (0.00%)	3/68 (4.41%)	0/24 (0.00%)	3/75 (4.00%)
Acute left ventricular failure † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Acute myocardial infarction (AMI) † 1	1/51 (1.96%)	2/24 (8.33%)	2/68 (2.94%)	1/24 (4.17%)	3/75 (4.00%)
Anginal equivalent † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Aortic valve stenosis † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Atrial fibrillation † 1	1/51 (1.96%)	2/24 (8.33%)	3/68 (4.41%)	0/24 (0.00%)	3/75 (4.00%)
Complete atrioventricular block † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Bradycardia † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Cardiac arrest † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Cardiomyopathy † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Coronary artery disease † 1	1/51 (1.96%)	1/24 (4.17%)	2/68 (2.94%)	1/24 (4.17%)	2/75 (2.67%)
Coronary artery stenosis † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Pericarditis † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Supraventricular tachycardia † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Angina pectoris † 1	0/51 (0.00%)	1/24 (4.17%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Angina unstable † 1	0/51 (0.00%)	1/24 (4.17%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Myocardial infarction (MI) † 1	0/51 (0.00%)	1/24 (4.17%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Eye disorders
Amaurosis fugax † 1	0/51 (0.00%)	1/24 (4.17%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Gastrointestinal disorders
Abdominal pain † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Colitis † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Melena † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Small intestinal obstruction † 1	1/51 (1.96%)	1/24 (4.17%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Retroperitoneal hemorrhage † 1	0/51 (0.00%)	1/24 (4.17%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
General disorders
Chest pain † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Chills † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Non-cardiac chest pain † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Pyrexia † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Infections and infestations
Pneumonia † 1	4/51 (7.84%)	0/24 (0.00%)	4/68 (5.88%)	0/24 (0.00%)	4/75 (5.33%)
Corona virus infection † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Cystitis † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Influenza † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Osteomyelitis † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Pneumona influenzal † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Sepsis † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Urosepsis † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Cellulitis † 1	0/51 (0.00%)	1/24 (4.17%)	1/68 (1.47%)	1/24 (4.17%)	1/75 (1.33%)
Localized infection † 1	0/51 (0.00%)	1/24 (4.17%)	0/68 (0.00%)	1/24 (4.17%)	1/75 (1.33%)
Viral pneumonia † 1	0/51 (0.00%)	1/24 (4.17%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Injury, poisoning and procedural complications
Humerus fracture † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Joint dislocation † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Investigations
Troponin increased † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Abnormal urine analysis † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Metabolism and nutrition disorders
Hypovolemia † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Dehydration † 1	0/51 (0.00%)	1/24 (4.17%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Hyponatremia † 1	0/51 (0.00%)	1/24 (4.17%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Musculoskeletal and connective tissue disorders
Musculoskeletal pain † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Neck pain † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Flank pain † 1	0/51 (0.00%)	1/24 (4.17%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Muscular weakness † 1	0/51 (0.00%)	1/24 (4.17%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic lung cancer † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Squamous cell carcinoma † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Nervous system disorders
Basal ganglia hemorrhage † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Cerebrovascular accident † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Dizziness † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Transient ischemic attack (TIA) † 1	0/51 (0.00%)	1/24 (4.17%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Renal and urinary disorders
Acute kidney injury † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Glomerulonephritis † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Micturition urgency † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Renal failure † 1	0/51 (0.00%)	1/24 (4.17%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure † 1	6/51 (11.76%)	3/24 (12.50%)	8/68 (11.76%)	1/24 (4.17%)	9/75 (12.00%)
Dyspnea † 1	5/51 (9.80%)	1/24 (4.17%)	6/68 (8.82%)	0/24 (0.00%)	6/75 (8.00%)
Pulmonary edema † 1	2/51 (3.92%)	0/24 (0.00%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Pleural effusion † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Pulmonary embolism † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Respiratory failure † 1	1/51 (1.96%)	1/24 (4.17%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Acute respiratory distress syndrome † 1	0/51 (0.00%)	1/24 (4.17%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Chronic obstructive pulmonary disease † 1	0/51 (0.00%)	1/24 (4.17%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Chronic respiratory failure † 1	0/51 (0.00%)	1/24 (4.17%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Pleuritic pain † 1	0/51 (0.00%)	1/24 (4.17%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Pneumothorax † 1	0/51 (0.00%)	1/24 (4.17%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Skin and subcutaneous tissue disorders
Skin ulcer † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Hyperhidrosis † 1	0/51 (0.00%)	1/24 (4.17%)	0/68 (0.00%)	1/24 (4.17%)	1/75 (1.33%)
Surgical and medical procedures
Toe amputation † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Lung transplant † 1	0/51 (0.00%)	1/24 (4.17%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Vascular disorders
Deep vein thrombosis † 1	1/51 (1.96%)	0/24 (0.00%)	1/68 (1.47%)	0/24 (0.00%)	1/75 (1.33%)
Hypotension † 1	1/51 (1.96%)	1/24 (4.17%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Superficial thrombophlebitis † 1	0/51 (0.00%)	1/24 (4.17%)	0/68 (0.00%)	1/24 (4.17%)	1/75 (1.33%)
1 Term from vocabulary, MedDRA 20.0; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	2%
	Belumosudil-R	BSC-R	Belumosudil-WC	BSC-NC	Total
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	50/51 (98.04%)	23/24 (95.83%)	67/68 (98.53%)	19/24 (79.17%)	73/75 (97.33%)
Blood and lymphatic system disorders
Leukocytosis † 1	3/51 (5.88%)	0/24 (0.00%)	3/68 (4.41%)	0/24 (0.00%)	3/75 (4.00%)
Anemia † 1	2/51 (3.92%)	1/24 (4.17%)	2/68 (2.94%)	1/24 (4.17%)	3/75 (4.00%)
Thrombocytopenia † 1	2/51 (3.92%)	0/24 (0.00%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Cardiac disorders
Supraventricular tachycardia † 1	4/51 (7.84%)	1/24 (4.17%)	5/68 (7.35%)	0/24 (0.00%)	5/75 (6.67%)
Atrial fibrillation † 1	3/51 (5.88%)	2/24 (8.33%)	5/68 (7.35%)	0/24 (0.00%)	5/75 (6.67%)
Congestive cardiac failure † 1	3/51 (5.88%)	1/24 (4.17%)	4/68 (5.88%)	0/24 (0.00%)	4/75 (5.33%)
Coronary artery disease † 1	2/51 (3.92%)	2/24 (8.33%)	4/68 (5.88%)	1/24 (4.17%)	4/75 (5.33%)
Acute myocardial infarction (AMI) † 1	1/51 (1.96%)	2/24 (8.33%)	2/68 (2.94%)	1/24 (4.17%)	3/75 (4.00%)
Angina pectoris † 1	1/51 (1.96%)	1/24 (4.17%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Ear and labyrinth disorders
Vertigo † 1	2/51 (3.92%)	0/24 (0.00%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Ear pain † 1	1/51 (1.96%)	1/24 (4.17%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Tinnitus † 1	1/51 (1.96%)	1/24 (4.17%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Endocrine disorders
Hypothyroidism † 1	1/51 (1.96%)	1/24 (4.17%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Eye disorders
Vision blurred † 1	2/51 (3.92%)	0/24 (0.00%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Gastrointestinal disorders
Diarrhea † 1	12/51 (23.53%)	6/24 (25.00%)	18/68 (26.47%)	0/24 (0.00%)	18/75 (24.00%)
Nausea † 1	6/51 (11.76%)	4/24 (16.67%)	8/68 (11.76%)	3/24 (12.50%)	10/75 (13.33%)
Upper abdominal pain † 1	3/51 (5.88%)	1/24 (4.17%)	4/68 (5.88%)	0/24 (0.00%)	4/75 (5.33%)
Constipation † 1	3/51 (5.88%)	1/24 (4.17%)	4/68 (5.88%)	0/24 (0.00%)	4/75 (5.33%)
Abdominal discomfort † 1	2/51 (3.92%)	0/24 (0.00%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Hiatus hernia † 1	2/51 (3.92%)	0/24 (0.00%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Vomiting † 1	2/51 (3.92%)	1/24 (4.17%)	3/68 (4.41%)	0/24 (0.00%)	3/75 (4.00%)
Dysphagia † 1	1/51 (1.96%)	1/24 (4.17%)	1/68 (1.47%)	1/24 (4.17%)	2/75 (2.67%)
Gastroesophageal reflux disease (GERD) † 1	1/51 (1.96%)	1/24 (4.17%)	1/68 (1.47%)	1/24 (4.17%)	2/75 (2.67%)
Inguinal hernia † 1	1/51 (1.96%)	1/24 (4.17%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
General disorders
Fatigue † 1	7/51 (13.73%)	4/24 (16.67%)	11/68 (16.18%)	1/24 (4.17%)	11/75 (14.67%)
Peripheral edema † 1	5/51 (9.80%)	1/24 (4.17%)	6/68 (8.82%)	0/24 (0.00%)	6/75 (8.00%)
Chills † 1	4/51 (7.84%)	0/24 (0.00%)	4/68 (5.88%)	0/24 (0.00%)	4/75 (5.33%)
Catheter site pain † 1	2/51 (3.92%)	0/24 (0.00%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Non-cardiac chest pain † 1	2/51 (3.92%)	2/24 (8.33%)	2/68 (2.94%)	2/24 (8.33%)	4/75 (5.33%)
Pyrexia † 1	2/51 (3.92%)	0/24 (0.00%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Pain † 1	1/51 (1.96%)	1/24 (4.17%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Small intestinal obstruction † 1	1/51 (1.96%)	1/24 (4.17%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Infections and infestations
Viral upper respiratory tract infection † 1	8/51 (15.69%)	5/24 (20.83%)	11/68 (16.18%)	2/24 (8.33%)	13/75 (17.33%)
Bronchitis † 1	7/51 (13.73%)	5/24 (20.83%)	7/68 (10.29%)	5/24 (20.83%)	12/75 (16.00%)
Pneumonia † 1	7/51 (13.73%)	0/24 (0.00%)	7/68 (10.29%)	0/24 (0.00%)	7/75 (9.33%)
Upper respiratory tract infection † 1	5/51 (9.80%)	6/24 (25.00%)	8/68 (11.76%)	4/24 (16.67%)	11/75 (14.67%)
Viral gastroenteritis † 1	4/51 (7.84%)	0/24 (0.00%)	4/68 (5.88%)	0/24 (0.00%)	4/75 (5.33%)
Sinusitis † 1	3/51 (5.88%)	0/24 (0.00%)	3/68 (4.41%)	0/24 (0.00%)	3/75 (4.00%)
Tooth infection † 1	3/51 (5.88%)	0/24 (0.00%)	3/68 (4.41%)	0/24 (0.00%)	3/75 (4.00%)
Cellulitis † 1	2/51 (3.92%)	2/24 (8.33%)	4/68 (5.88%)	1/24 (4.17%)	4/75 (5.33%)
Corona virus infection † 1	2/51 (3.92%)	0/24 (0.00%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Influenza † 1	2/51 (3.92%)	1/24 (4.17%)	3/68 (4.41%)	0/24 (0.00%)	3/75 (4.00%)
Rhinitis † 1	2/51 (3.92%)	1/24 (4.17%)	3/68 (4.41%)	0/24 (0.00%)	3/75 (4.00%)
Urinary tract infection † 1	2/51 (3.92%)	1/24 (4.17%)	2/68 (2.94%)	1/24 (4.17%)	3/75 (4.00%)
Viral infection † 1	2/51 (3.92%)	0/24 (0.00%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Injury, poisoning and procedural complications
Fall † 1	4/51 (7.84%)	1/24 (4.17%)	4/68 (5.88%)	1/24 (4.17%)	5/75 (6.67%)
Stress fracture † 1	2/51 (3.92%)	0/24 (0.00%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Head injuries † 1	1/51 (1.96%)	1/24 (4.17%)	2/68 (2.94%)	1/24 (4.17%)	2/75 (2.67%)
Joint injury † 1	1/51 (1.96%)	1/24 (4.17%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Limb injury † 1	1/51 (1.96%)	1/24 (4.17%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Muscle strain † 1	1/51 (1.96%)	1/24 (4.17%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Tooth fracture † 1	1/51 (1.96%)	1/24 (4.17%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Investigations
Alanine aminotransferase (ALT) increased † 1	8/51 (15.69%)	3/24 (12.50%)	10/68 (14.71%)	1/24 (4.17%)	11/75 (14.67%)
Aspartate aminotransferase (AST) increased † 1	6/51 (11.76%)	2/24 (8.33%)	8/68 (11.76%)	0/24 (0.00%)	8/75 (10.67%)
Gamma-glutamyltransferase (GGT) increased † 1	5/51 (9.80%)	3/24 (12.50%)	6/68 (8.82%)	2/24 (8.33%)	8/75 (10.67%)
Blood creatinine increased † 1	3/51 (5.88%)	1/24 (4.17%)	3/68 (4.41%)	1/24 (4.17%)	4/75 (5.33%)
Prothrombin time prolonged † 1	2/51 (3.92%)	0/24 (0.00%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Weight decreased † 1	3/51 (5.88%)	0/24 (0.00%)	3/68 (4.41%)	0/24 (0.00%)	3/75 (4.00%)
Weight increased † 1	2/51 (3.92%)	0/24 (0.00%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Blood glucose increased † 1	1/51 (1.96%)	1/24 (4.17%)	1/68 (1.47%)	1/24 (4.17%)	2/75 (2.67%)
Blood lactate dehydrogenase (LDH) increased † 1	1/51 (1.96%)	1/24 (4.17%)	1/68 (1.47%)	1/24 (4.17%)	2/75 (2.67%)
Blood thyroid stimulating hormone (TSH) increased † 1	1/51 (1.96%)	3/24 (12.50%)	3/68 (4.41%)	1/24 (4.17%)	4/75 (5.33%)
Blood urea increased † 1	1/51 (1.96%)	1/24 (4.17%)	1/68 (1.47%)	1/24 (4.17%)	2/75 (2.67%)
Hepatic enzyme increased † 1	1/51 (1.96%)	2/24 (8.33%)	3/68 (4.41%)	0/24 (0.00%)	3/75 (4.00%)
Electrocardiogram (ECG) ST-segment abnormal † 1	0/51 (0.00%)	2/24 (8.33%)	1/68 (1.47%)	1/24 (4.17%)	2/75 (2.67%)
ECG T-wave abnormal † 1	0/51 (0.00%)	2/24 (8.33%)	1/68 (1.47%)	1/24 (4.17%)	2/75 (2.67%)
Metabolism and nutrition disorders
Decreased appetite † 1	5/51 (9.80%)	0/24 (0.00%)	5/68 (7.35%)	0/24 (0.00%)	5/75 (6.67%)
Hyperglycemia † 1	2/51 (3.92%)	1/24 (4.17%)	3/68 (4.41%)	0/24 (0.00%)	3/75 (4.00%)
Dehydration † 1	1/51 (1.96%)	1/24 (4.17%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Hyponatremia † 1	1/51 (1.96%)	1/24 (4.17%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Type 2 diabetes mellitus † 1	1/51 (1.96%)	1/24 (4.17%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Musculoskeletal and connective tissue disorders
Back pain † 1	5/51 (9.80%)	4/24 (16.67%)	7/68 (10.29%)	2/24 (8.33%)	9/75 (12.00%)
Arthralgia † 1	4/51 (7.84%)	0/24 (0.00%)	4/68 (5.88%)	0/24 (0.00%)	4/75 (5.33%)
Muscle spasms † 1	4/51 (7.84%)	3/24 (12.50%)	5/68 (7.35%)	2/24 (8.33%)	7/75 (9.33%)
Costcochondritis † 1	3/51 (5.88%)	0/24 (0.00%)	3/68 (4.41%)	0/24 (0.00%)	3/75 (4.00%)
Musculoskeletal pain † 1	3/51 (5.88%)	1/24 (4.17%)	3/68 (4.41%)	1/24 (4.17%)	4/75 (5.33%)
Clubbing † 1	2/51 (3.92%)	0/24 (0.00%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Joint swelling † 1	2/51 (3.92%)	0/24 (0.00%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Musculoskeletal chest pain † 1	2/51 (3.92%)	0/24 (0.00%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Neck pain † 1	2/51 (3.92%)	0/24 (0.00%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Pain in extremity † 1	2/51 (3.92%)	0/24 (0.00%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Flank pain † 1	1/51 (1.96%)	1/24 (4.17%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Muscular weakness † 1	1/51 (1.96%)	2/24 (8.33%)	3/68 (4.41%)	0/24 (0.00%)	3/75 (4.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma † 1	3/51 (5.88%)	0/24 (0.00%)	3/68 (4.41%)	0/24 (0.00%)	3/75 (4.00%)
Nervous system disorders
Dizziness † 1	6/51 (11.76%)	2/24 (8.33%)	7/68 (10.29%)	1/24 (4.17%)	8/75 (10.67%)
Headache † 1	4/51 (7.84%)	1/24 (4.17%)	4/68 (5.88%)	1/24 (4.17%)	5/75 (6.67%)
Memory impairment † 1	4/51 (7.84%)	0/24 (0.00%)	4/68 (5.88%)	0/24 (0.00%)	4/75 (5.33%)
Hypoesthesia † 1	2/51 (3.92%)	0/24 (0.00%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Lethargy † 1	2/51 (3.92%)	0/24 (0.00%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Paresthesia † 1	2/51 (3.92%)	1/24 (4.17%)	3/68 (4.41%)	0/24 (0.00%)	3/75 (4.00%)
Balance disorder † 1	1/51 (1.96%)	1/24 (4.17%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Syncope † 1	1/51 (1.96%)	1/24 (4.17%)	1/68 (1.47%)	1/24 (4.17%)	2/75 (2.67%)
Psychiatric disorders
Anxiety † 1	6/51 (11.76%)	1/24 (4.17%)	7/68 (10.29%)	0/24 (0.00%)	7/75 (9.33%)
Insomnia † 1	4/51 (7.84%)	1/24 (4.17%)	5/68 (7.35%)	0/24 (0.00%)	5/75 (6.67%)
Depression † 1	3/51 (5.88%)	0/24 (0.00%)	3/68 (4.41%)	0/24 (0.00%)	3/75 (4.00%)
Panic attack † 1	1/51 (1.96%)	1/24 (4.17%)	1/68 (1.47%)	1/24 (4.17%)	2/75 (2.67%)
Renal and urinary disorders
Hematuria † 1	1/51 (1.96%)	1/24 (4.17%)	1/68 (1.47%)	1/24 (4.17%)	2/75 (2.67%)
Respiratory, thoracic and mediastinal disorders
Dyspnea † 1	19/51 (37.25%)	5/24 (20.83%)	21/68 (30.88%)	4/24 (16.67%)	24/75 (32.00%)
Cough † 1	14/51 (27.45%)	8/24 (33.33%)	14/68 (20.59%)	8/24 (33.33%)	22/75 (29.33%)
Acute respiratory failure † 1	6/51 (11.76%)	3/24 (12.50%)	8/68 (11.76%)	1/24 (4.17%)	9/75 (12.00%)
Exertional dyspnea † 1	3/51 (5.88%)	1/24 (4.17%)	3/68 (4.41%)	1/24 (4.17%)	4/75 (5.33%)
Productive cough † 1	3/51 (5.88%)	2/24 (8.33%)	4/68 (5.88%)	2/24 (8.33%)	5/75 (6.67%)
Pulmonary mass † 1	3/51 (5.88%)	2/24 (8.33%)	5/68 (7.35%)	0/24 (0.00%)	5/75 (6.67%)
Pulmonary edema † 1	3/51 (5.88%)	0/24 (0.00%)	3/68 (4.41%)	0/24 (0.00%)	3/75 (4.00%)
Epistaxis † 1	2/51 (3.92%)	0/24 (0.00%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Pulmonary hypertension † 1	2/51 (3.92%)	1/24 (4.17%)	3/68 (4.41%)	0/24 (0.00%)	3/75 (4.00%)
Rales † 1	2/51 (3.92%)	0/24 (0.00%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Upper airway cough syndrome † 1	2/51 (3.92%)	1/24 (4.17%)	3/68 (4.41%)	0/24 (0.00%)	3/75 (4.00%)
Chronic obstructive pulmonary disease † 1	1/51 (1.96%)	1/24 (4.17%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Chronic respiratory failure † 1	1/51 (1.96%)	1/24 (4.17%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Lower respiratory tract congestion † 1	1/51 (1.96%)	1/24 (4.17%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Oropharyngeal pain † 1	1/51 (1.96%)	2/24 (8.33%)	2/68 (2.94%)	1/24 (4.17%)	3/75 (4.00%)
Pleuritic pain † 1	1/51 (1.96%)	1/24 (4.17%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Pulmonary congestion † 1	1/51 (1.96%)	1/24 (4.17%)	1/68 (1.47%)	1/24 (4.17%)	2/75 (2.67%)
Respiratory failure † 1	1/51 (1.96%)	1/24 (4.17%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Sputum discolored † 1	1/51 (1.96%)	1/24 (4.17%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Throat irritation † 1	1/51 (1.96%)	1/24 (4.17%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Wheezing † 1	1/51 (1.96%)	1/24 (4.17%)	1/68 (1.47%)	1/24 (4.17%)	2/75 (2.67%)
Skin and subcutaneous tissue disorders
Dermal cyst † 1	2/51 (3.92%)	0/24 (0.00%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Erythema † 1	2/51 (3.92%)	0/24 (0.00%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Pruritus † 1	2/51 (3.92%)	1/24 (4.17%)	3/68 (4.41%)	0/24 (0.00%)	3/75 (4.00%)
Rash † 1	2/51 (3.92%)	0/24 (0.00%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Actinic keratosis † 1	0/51 (0.00%)	3/24 (12.50%)	2/68 (2.94%)	1/24 (4.17%)	3/75 (4.00%)
Vascular disorders
Hypertension † 1	2/51 (3.92%)	0/24 (0.00%)	2/68 (2.94%)	0/24 (0.00%)	2/75 (2.67%)
Hypotension † 1	2/51 (3.92%)	1/24 (4.17%)	3/68 (4.41%)	0/24 (0.00%)	3/75 (4.00%)
1 Term from vocabulary, MedDRA 20.0; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Karin Herrera, Vice President, Clinical Operations
• Organization: Kadmon Corporation
• Phone: 1-724-778-6134
• EMail: karin.herrera@kadmon.com

• Responsible Party: Kadmon Corporation, LLC
• ClinicalTrials.gov Identifier: NCT02688647
• Other Study ID Numbers: KD025-207
• First Submitted: February 18, 2016
• First Posted: February 23, 2016
• Results First Submitted: April 13, 2022
• Results First Posted: September 8, 2022
• Last Update Posted: September 8, 2022