A 2-Part, Phase 2 Open-label and Crossover Study of Belum... | NCT02688647 | Trialant
NCT02688647
Sponsor
Kadmon Corporation, LLC
Status
Completed
Last Update Posted
Sep 8, 2022Actual
Enrollment
76Actual
Phase
Phase 2
Conditions
Idiopathic Pulmonary Fibrosis
Interventions
Belumosudil
BSC
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02688647
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
KD025-207
Secondary IDs
Not provided
Brief Title
A 2-Part, Phase 2 Open-label and Crossover Study of Belumosudil for Treatment of Idiopathic Pulmonary Fibrosis
Official Title
A Randomized, Phase 2, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Activity of Belumosudil in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Acronym
Not provided
Organization
Kadmon Corporation, LLCINDUSTRY
Status Module
Record Verification Date
Sep 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 26, 2016Actual
Primary Completion Date
Apr 13, 2021Actual
Completion Date
Apr 13, 2021Actual
First Submitted Date
Feb 18, 2016
First Submission Date that Met QC Criteria
Feb 22, 2016
First Posted Date
Feb 23, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 13, 2022
Results First Submitted that Met QC Criteria
Sep 6, 2022
Results First Posted Date
Sep 8, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 6, 2022
Last Update Posted Date
Sep 8, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Kadmon Corporation, LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This Phase 2 study is to be conducted to evaluate the safety, tolerability, and activity of 400 mg of belumosudil orally (PO) once-daily (QD) compared to Best Supportive Care (BSC) in male and postmenopausal/surgically sterilized female subjects with Idiopathic Pulmonary Fibrosis (IPF). The primary objectives are to evaluate the:
Change in Forced Vital Capacity (FVC) from baseline to 24 weeks after dosing with belumosudil 400 mg PO QD in subjects with IPF compared to BSC
Safety and tolerability of belumosudil 400 mg PO QD when administered for 24 weeks to subjects with IPF compared to BSC
Detailed Description
Study KD025-207 is a Phase 2, randomized, 2-part, open-label, crossover study in subjects with IPF.
The purpose of the study is to evaluate the safety, tolerability, and activity of 400 mg of belumosudil administered orally (PO) every day (QD) compared to Best Standard of Care (BSC) in subjects with IPF who have previously been treated with or declined treatment with pirfenidone or nintedanib.
The primary objectives are to evaluate the change in Forced Vital Capacity (FVC), and the safety and tolerability from baseline to 24 weeks in subjects with IPF after dosing with belumosudil 400 mg PO QD compared to BSC.
Part 1: Randomized, Open-label for 24 Weeks
Approximately 81 eligible subjects with IPF are to be enrolled, in 10 to 15 sites, and randomized in a 2:1 ratio (belumosudil:BSC) to 1 of the following 2 groups:
Belumosudil-R (Investigational Group): Belumosudil 400 mg PO QD for 24 weeks
BSC-R (Control Group): BSC for 24 weeks
The study plan is for 54 subjects to be entered into the Belumosudil-R Treatment Group and 27 subjects into the BSC-R Treatment Group. This sample size provides over 90% power at the 2-sided 0.05 significance level to detect a 20% difference between treatment groups at 24 weeks in percentage change from baseline in FVC assuming a standard deviation (SD) in percentage change from baseline in FVC of 17%. The sample size of 54 subjects receiving belumosudil provides over 90% probability of ≥ 1 subject in the study experiencing an AE that had an underlying rate of ≥ 5%.
Part 2: Continuation of Belumosudil Therapy or Crossover to Belumosudil Therapy Subjects in the Belumosudil-R group who complete 24 weeks of treatment with belumosudil 400 mg PO QD have the option of continuing therapy with belumosudil 400 mg PO QD up to an additional 72 weeks if there are no safety signals and if clinical progress continues. No subject in the Belumosudil-R group is to be permitted to receive therapy with belumosudil greater than a total of 96 weeks.
Subjects in control group BSC-R who complete 24 weeks of BSC have the option of crossing over to therapy with belumosudil 400 mg PO QD for up to 96 weeks if there are no safety signals and if clinical progress continues. No subject in control group BSC-R is to be permitted to receive belumosudil 400 mg PO QD therapy greater than 96 weeks.
Follow-up Period:
Follow-up Visits are to occur 30 days (± 3 days) after the last dose of belumosudil during which subjects are to undergo safety assessments. (A Follow-up Visit is not necessary for subjects receiving BSC.)
Duration of Study for Individual Subjects:
Subjects randomized to belumosudil: total up to 104 weeks (4-week screening, 96-week treatment with belumosudil, and 4-week follow-up)
Subject randomized to BSC: total up to 128 weeks (4-week screening; up to 24-week treatment with BSC, 96-week treatment with belumosudil, and 4-week follow-up)
Efficacy Assessments
FVC
FVC% Predicted
6-minute Walking Distance (6MWD)
Diffusing Capacity of Carbon Monoxide (DLCO)
Lung Fibrosis (by HRCT and Radiologist's Visual Assessments)
Time to Acute Exacerbation
Time to Progression of IPF
Time to Respiratory-related Hospitalization
Time to Respiratory-related Death
St. Georges Respiratory Questionnaire (SGRQ)
Biomarker Assessments
Matrix Metalloproteinase-7 (MMP7)
Chemokine Ligand 18 (CCL18)
Surfactant Protein-D (SPD)
Safety Assessments
Adverse event (AE)
Serious adverse event (SAE)
Physical examination (PE)
Vital signs (VS)
Clinical laboratory evaluations (hematology, chemistry, and urinalysis)
Electrocardiogram (ECG)
Reason for treatment discontinuation due to toxicity
Analyses
Efficacy and safety are to be analyzed at the end of Part 1 (Week 24) and for the Entire Treatment Period (Parts 1 and 2). Analyses of study subjects are to be grouped and defined as follows:
Belumosudil-R: subjects randomized to belumosudil
BSC-R: subjects randomized to BSC
Belumosudil-WC: subjects randomized to belumosudil plus subjects randomized to BSC and who cross over to treatment with belumosudil
BSC-NC: subjects randomized to BSC and who cross over to treatment with belumosudil but have data censored by the date of crossover
Conditions Module
Conditions
Idiopathic Pulmonary Fibrosis
Keywords
Pulmonary Fibrosis
Fibrosis
Idiopathic Interstitial Pneumonias
Lung Diseases
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
76Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Belumosudil-R
Experimental
Subjects receive two 200 mg tablets of belumosudil (400 mg) PO QD for 24 weeks. Subjects may also continue treatment with belumosudil 400 mg PO QD after 24 weeks.
No subject may receive more than 96 weeks of treatment with belumosudil
Drug: Belumosudil
BSC-R
Active Comparator
Subjects receive best supportive care as determined by the physician. Subjects may later crossover to treatment with belumosudil 400 mg PO QD. No subject may receive more than 96 weeks of treatment with belumosudil.
Other: BSC
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Belumosudil
Drug
Belumosudil-R
KD025
SLx-2119
BSC
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Efficacy: Mean Changes in FVC From Baseline to Week 24
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
24 weeks
Efficacy: Mean Changes in FVC% Predicted From Baseline at Week 24
Changes in the mean Forced Vital Capacity (FVC)% Predicted from baseline at Week 24.
Normal FVC%: 80% to 120%
24 weeks
Safety: Percentages of Subjects With Non-serious TEAEs and Relationship to Study Treatment
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).
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.
Safety: Percentages of Subjects With SAEs Related to Study Treatment
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.
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.
Safety: Percentages of Subjects With TEAEs Leading to Discontinuation of Treatment With Belumosudil
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.
Secondary Outcomes
Measure
Description
Time Frame
Efficacy: Mean Changes in FVC From Baseline at Week 24 by GAP Stage and by Use of Pirfenidone or Nintedanib--
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:
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
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
A subject had to meet all of the following criteria to be eligible for the study:
Adult male and postmenopausal/surgically sterilized female subjects at least 18 years of age (if female, was surgically sterilized [i.e., total hysterectomy, or bilateral salpingo-oophorectomy]).
Able to provide written informed consent before the performance of any study specific procedures.
IPF diagnosis within 5 years before study entry, proven according to the American Thoracic Society/European Respiratory Society consensus conference criteria, with surgical lung biopsy. In the absence of a surgical lung biopsy, high-resolution computerized tomography (HRCT) consistent with usual interstitial pneumonitis.
Resting state pulse oximeter oxygen saturation (SpO2) ≥ 88% with or without supplemental oxygen, Forced Vital Capacity % (FVC%) ≥ 50% normal predicted value, and diffusing capcity (in the lung) of carbon monoxide (DLCO) ≥ 30% normal predicted value at baseline.
Men with partners of childbearing potential willing to use 2 medically acceptable methods of contraception during the trial and for 3 months after the last dose of study drug. Effective birth control includes:
Intrauterine device plus 1 barrier method
Stable doses of hormonal contraception for ≥ 3 months (e.g., oral, injectible, implant, transdermal) plus 1 barrier method
2 barrier methods. Effective barrier methods were male or female condoms, diaphragms, and spermicides (creams or gels containing a chemical to kill sperm)
Vasectomy.
Have adequate bone marrow function:
Absolute neutrophil count > 1500/mm^3
Hemoglobin (Hb) > 9.0 g/L
Platelets > 100,000/mm^3
Willing to complete all study measurements and assessments in compliance with protocol
Had either received pirfenidone and/or nintedanib or offered both treatments (with last dose administered at least 1 month before the expected start of study drug dosing). If either or both pirfenidone and nintedanib treatment had not been given, then documentation that the subject was offered both treatments must have been documented.
Exclusion Criteria:
A subject who met any of the following criteria was ineligible for the study:
Interstitial lung disease caused by conditions other than IPF
Severe concomitant illness limiting life expectancy (< 1 year)
DLCO < 30% predicted
Residual volume (RV) ≥ 120% predicted
Obstructive lung disease: Forced Expiratory Volume in 1 Second (FEV1/FVC ratio < 0.70)
Documented sustained improvement of the subject's IPF condition up to 12 months before study entry with or without IPF-specific therapy
Pulmonary infection or upper respiratory tract infection (URTI) within 4 weeks before study entry
Acute or chronic impairment (other than dyspnea) limiting the ability to comply with study requirements (e.g., pulmonary function tests [PFTs])
Chronic heart failure with New York Heart Association Class III/IV or known left ventricular ejection fraction < 25%
Moderate to severe hepatic impairment (i.e., Child-Pugh Class B or C)
Estimated creatinine clearance < 30 mL/min
Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2.0 * upper limit of normal (ULN)
Hb < 75% of the lower limit of normal
Systolic blood pressure < 100 mmHg
Pregnant or breastfeeding female subject
Men whose partner is pregnant or breastfeeding
Current drug or alcohol dependence
Chronic treatment with the following drugs within 4 weeks of study entry and during the study:
Immunosuppressive or cytotoxic drugs including cyclophosphamide and azathioprine
Antifibrotic drugs including pirfenidone, nintedanib, D-penicillamine, colchicine, tumor necrosis factor-alpha blockers, imatinib, and interferon-γ
Chronic use of N-acetylcysteine prescribed for IPF (> 600 mg/day)
Oral anticoagulants prescribed for IPF
Treatment with endothelin receptor antagonists within 4 weeks before study entry
Systemic treatment within 4 weeks before study entry with cyclosporine A or tacrolimus, everolimus, or sirolimus (calcineurin or mammalian target of rapamycin inhibitors)
Previous exposure to belumosudil or known allergy/sensitivity to belumosudil or any other Rho-associated protein kinase 2 (ROCK2) inhibitor
Planned treatment or treatment with another investigational drug within 4 weeks before study entry
Taking a medication with the potential for QTc prolongation
Taking a drug sensitive substrate of CYP enzymes
Taking a strong inducer of CYP3A4
Had consumed an herbal medication (e.g., St. John's Wort) or grapefruit/grapefruit juice within 14 days prior to the Week 1 Day 1 visit
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Pulmonary Associates, PA
Phoenix
Arizona
85006
United States
University of Arizona
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
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.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Belumosudil-R
Subjects randomized to treatment with belumosudil 400 mg orally (PO) once daily 9QD).
FG001
BSC-R
Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.
Periods
Title
Milestones
Reasons Not Completed
Initial Treatment Period (24 Weeks)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
2
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Mar 3, 2020
Apr 13, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
In Part 1: Subjects are randomized to treatment with either Belumosudil 400 mg PO QD (Belumosudil-R) or to BSC (BSC-R).
In Part 2: Subjects who are randomized and receive Belumosudil 400 mg PO QD during Part 1 have the option to continue treatment with Belumosudil 400 mg PO QD and subjects randomized to BSC have the option to cross over to treatment with Belumosudil 400 mg PO QD.
No subject is permitted > 96 weeks of treatment with belumosudil
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Other
Treatment/drug as determined by each subject's prescribing physician
BSC-R
Best standard of care
Up to 96 weeks (Weeks 24, 48, and 96) of treatment with belumosudil
Safety: Percentages of Subjects With Deaths Related to Study Treatment
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.
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.
24 weeks
Efficacy: Mean Changes in FVC From Baseline at Week 48, Week 96, and EOT
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
Up to 96 weeks (Weeks 24, 48, and 96)
Efficacy: Mean Change in Mean FEV1/FVC Ratio From Baseline at Weeks 24, 48, and 96 and EOT
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
Up to 96 weeks (Weeks 24, 48, and 96)
Efficacy: Mean Changes in FVC% Predicted at Week 24 by GAP Stage and by Use of Pirfenidone or Nintedanib--
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:
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
24 weeks
Efficacy: Percentages of Subjects With Decrease ≥ 5% in FVC% Predicted From Baseline at Weeks 24, 48, and 96
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
Up to 96 weeks (Weeks 24, 48, and 96)
Efficacy: Percentage of Subjects With Decrease ≥ 10% in FVC% Predicted at Weeks 24, 48, and 96
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
Up to 96 weeks (Weeks 24, 48, and 96)
Efficacy: Mean Change in 6MWD at Weeks 24, 48, and 96
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.
Efficacy: Percentages of Subjects With ≥ 50 Meter Improvement in 6MWD at Weeks 24, 48, and 96
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.
Up to 96 weeks (Weeks 24, 48, and 96)
Efficacy: Mean Changes in DLCO (%) at Weeks 24, 48, and 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%
Up to 96 weeks (Weeks 24, 48, and 96)
Efficacy: Percentages of Subjects With Change From Baseline in DLCO (%) ≤ -15% at Weeks 24, 48, and 96
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%
Up to 96 weeks (Weeks 24, 48, and 96)
Efficacy: Mean Changes in Total Lung Fibrosis Score, by HRCT, From Baseline at Weeks 24, 48, and 96
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.
Up to 96 weeks (Weeks 24, 48, and 96)
Efficacy: Categorical Changes in Lung Fibrosis as Observed by Sequential Scans of Radiologist Visual Assessment, From Baseline at Weeks 24, 48, and 96
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).
Up to 96 weeks (Weeks 24, 48, and 96)
Efficacy: Changes in Mean DTA Lung Fibrosis Score, by Radiologist Visual Assessment, From Baseline at Weeks 24, 48, and 96
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.
Up to 96 Weeks (Weeks 24, 48, and 96)
Efficacy: Event-free Probability of Acute Exacerbation of IPF
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.
Up to 96 weeks (Weeks 24, 48, and 96)
Efficacy: Event-free Probability of Progression of IPF
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.
Up to 96 weeks (Weeks 24, 48, and 96)
Efficacy: Event-free Probability of First Respiratory-related Hospitalization
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.
Up to 96 weeks (Weeks 24, 48, and 96)
Efficacy: Event-free Probability of Respiratory-related Death
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.
Up to 96 weeks (Weeks 24, 48, and 96)
Efficacy: Mean Changes in SGRQ From Baseline at Weeks 24, 48 and 96
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
Up to 96 weeks (Weeks 24, 48, and 96)
Tucson
Arizona
85724
United States
UC Davis Medical Center, Division of Pulmonary/CC/SM
Sacramento
California
95817
United States
St. Francis Medical Institute
Clearwater
Florida
33765
United States
Pulmonary Disease Specialists, PA, d/b/a PDS Research
Kissimmee
Florida
34741
United States
Central Florida Pulmonary Group, PA
Orlando
Florida
32803
United States
Piedmont Healthcare Pulmonary and Critical Care Research
Austell
Georgia
30106
United States
Pulmonix, LLC
Greensboro
North Carolina
27403
United States
University of Pittsburgh Medical Center
Pittsburgh
Pennsylvania
15213
United States
Medical University of South Carolina
Charleston
South Carolina
29425
United States
FG00052 subjects
FG00124 subjects
Treated
FG00051 subjects1 subject was randomized but did not receive treatment.
FG00124 subjects
COMPLETED
FG00051 subjects
FG00118 subjects
NOT COMPLETED
FG0001 subjects
FG0016 subjects
Type
Comment
Reasons
Death
FG0000 subjects
FG0011 subjects
Cross-overed before Initial Treatment Period (24 Weeks)
FG0000 subjects
FG0015 subjects
Subject was randomized but did not receive treatment
FG0001 subjects
FG0010 subjects
Post Switch Treatment Period (72 Weeks)
Type
Comment
Milestone Data
STARTED
FG00051 subjects51 subjects originally randomized to treatment with belumosudil 400 mg PO QD continued receiving belumosudil 400 mg PO QD.
FG00117 subjects17 subjects randomized to treatment with BSC-R cross-overed to treatment with belumosudil 400 mg PO QD.
COMPLETED
FG00023 subjects
FG0013 subjects
NOT COMPLETED
FG00028 subjects
FG00114 subjects
Type
Comment
Reasons
Death
FG0007 subjects
FG0012 subjects
Lost to Follow-up
FG0001 subjects
FG001
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.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Belumosudil 400 mg PO QD
Randomized to treatment with belumosudil 400 mg (two 200-mg tablets) orally once daily.
BG001
BSC-R
Subjects randomized to treatment with best supportive care for 24 weeks.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00051
BG00124
BG00275
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00072.5± 7.0
BG00174.9± 5.9
BG00273.3± 6.7
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00013
BG0016
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0006
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Prior Use of Pirfenidone
Count of Participants
Participants
Title
Denominators
Categories
Yes
Title
Measurements
BG00013
BG0014
BG002
Prior Use of Nintedanib
Count of Participants
Participants
Title
Denominators
Categories
Yes
Title
Measurements
BG00010
BG0014
BG002
Prior Use of Pirfenidone or Nintedanib
Count of Participants
Participants
Title
Denominators
Categories
Yes
Title
Measurements
BG00019
BG0016
BG002
GAP Stage
GAP = Gender/Age/Physiology. Stage based on total points.
Presence of Aggravated Dyspnea Within 6 Months Prior to Informed Consent
Count of Participants
Participants
Title
Denominators
Categories
Yes
Title
Measurements
BG00018
BG00111
BG002
Presence of Chest Interstitial Lung Abnormalities Within 6 Months Prior to Informed Consent
Count of Participants
Participants
Title
Denominators
Categories
Yes
Title
Measurements
BG00023
BG00111
BG002
SpO2 < 88% Within 6 Months Prior to Informed Consent
Count of Participants
Participants
Title
Denominators
Categories
Yes
Title
Measurements
BG0007
BG0014
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Efficacy: Mean Changes in FVC From Baseline to Week 24
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
Analysis was performed using randomized population. Available data for change from baseline at Week 24 have been reported.
Posted
Mean
Standard Deviation
mL
24 weeks
ID
Title
Description
OG000
Belumosudil-R
Subjects randomized to treatment with belumosudil 400 mg orally (PO) once daily 9QD)
OG001
BSC-R
Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.
OG002
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
OG003
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
OG004
Total
Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Units
Counts
Participants
OG00052
OG00124
OG00269
OG003
Title
Denominators
Categories
Baseline
ParticipantsOG00052
ParticipantsOG00124
ParticipantsOG00264
ParticipantsOG003
Primary
Efficacy: Mean Changes in FVC% Predicted From Baseline at Week 24
Changes in the mean Forced Vital Capacity (FVC)% Predicted from baseline at Week 24.
Normal FVC%: 80% to 120%
Analysis was performed using randomized population. Available data for change from baseline at Week 24 have been reported.
Posted
Mean
Standard Deviation
% of predicted
24 weeks
ID
Title
Description
OG000
Belumosudil-R
Subjects randomized to treatment with belumosudil 400 mg orally once daily.
OG001
BSC-R
Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.
OG002
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
OG003
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
Primary
Safety: Percentages of Subjects With Non-serious TEAEs and Relationship to Study Treatment
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).
All subjects treated in study.
Posted
Count of Participants
Participants
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.
ID
Title
Description
OG000
Belumosudil-R
Subjects randomized to treatment with belumosudil 400 mg orally once daily.
OG001
BSC-R
Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.
OG002
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
OG003
Primary
Safety: Percentages of Subjects With SAEs Related to Study Treatment
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.
All subjects treated in study.
Posted
Count of Participants
Participants
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.
ID
Title
Description
OG000
Belumosudil-R
Subjects randomized to treatment with belumosudil 400 mg orally once daily.
OG001
BSC-R
Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.
OG002
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
OG003
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
Primary
Safety: Percentages of Subjects With TEAEs Leading to Discontinuation of Treatment With Belumosudil
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.
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.
Posted
Count of Participants
Participants
Up to 96 weeks (Weeks 24, 48, and 96) of treatment with belumosudil
ID
Title
Description
OG000
Belumosudil-R
Subjects randomized to treatment with belumosudil 400 mg orally once daily.
OG001
BSC-R
Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.
OG002
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
OG003
Primary
Safety: Percentages of Subjects With Deaths Related to Study Treatment
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.
All subjects treated in study.
Posted
Count of Participants
Participants
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.
ID
Title
Description
OG000
Belumosudil-R
Subjects randomized to treatment with belumosudil 400 mg orally once daily.
OG001
BSC-R
Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.
OG002
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
OG003
BSC-NC
Secondary
Efficacy: Mean Changes in FVC From Baseline at Week 24 by GAP Stage and by Use of Pirfenidone or Nintedanib--
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:
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
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.
Posted
Geometric Least Squares Mean
95% Confidence Interval
mL
24 weeks
ID
Title
Description
OG000
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
OG001
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
Secondary
Efficacy: Mean Changes in FVC From Baseline at Week 48, Week 96, and EOT
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
All randomized subjects
Posted
Mean
Standard Deviation
mL
Up to 96 weeks (Weeks 24, 48, and 96)
ID
Title
Description
OG000
Belumosudil-R
Subjects randomized to treatment with belumosudil 400 mg orally once daily.
OG001
BSC-R
Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.
OG002
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
OG003
Total
Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Secondary
Efficacy: Mean Change in Mean FEV1/FVC Ratio From Baseline at Weeks 24, 48, and 96 and EOT
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
All randomized subjects
Posted
Mean
Standard Deviation
Units
Up to 96 weeks (Weeks 24, 48, and 96)
ID
Title
Description
OG000
Belumosudil-R
Subjects randomized to treatment with belumosudil 400 mg orally once daily.
OG001
BSC-R
Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.
OG002
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
OG003
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
Secondary
Efficacy: Mean Changes in FVC% Predicted at Week 24 by GAP Stage and by Use of Pirfenidone or Nintedanib--
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:
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
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.
Posted
Geometric Least Squares Mean
95% Confidence Interval
% of predicted
24 weeks
ID
Title
Description
OG000
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
OG001
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
Secondary
Efficacy: Percentages of Subjects With Decrease ≥ 5% in FVC% Predicted From Baseline at Weeks 24, 48, and 96
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
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.
Posted
Count of Participants
Participants
Up to 96 weeks (Weeks 24, 48, and 96)
ID
Title
Description
OG000
Belumosudil-R
Subjects randomized to treatment with belumosudil 400 mg orally once daily.
OG001
BSC-R
Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.
OG002
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
OG003
BSC-NC
Secondary
Efficacy: Percentage of Subjects With Decrease ≥ 10% in FVC% Predicted at Weeks 24, 48, and 96
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
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.
Posted
Count of Participants
Participants
Up to 96 weeks (Weeks 24, 48, and 96)
ID
Title
Description
OG000
Belumosudil-R
Subjects randomized to treatment with belumosudil 400 mg orally once daily.
OG001
BSC-R
Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.
OG002
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
OG003
BSC-NC
Secondary
Efficacy: Mean Change in 6MWD at Weeks 24, 48, and 96
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.
Subjects randomized to treatment with belumosudil 400 mg orally once daily.
OG001
BSC-R
Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.
OG002
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
OG003
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
Secondary
Efficacy: Percentages of Subjects With ≥ 50 Meter Improvement in 6MWD at Weeks 24, 48, and 96
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.
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.
Posted
Count of Participants
Participants
Up to 96 weeks (Weeks 24, 48, and 96)
ID
Title
Description
OG000
Belumosudil-R
Subjects randomized to treatment with belumosudil 400 mg orally once daily.
OG001
BSC-R
Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.
OG002
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
OG003
BSC-NC
Secondary
Efficacy: Mean Changes in DLCO (%) at Weeks 24, 48, and 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%
All randomized subjects
Posted
Mean
Standard Deviation
% of diffusing capacity of CO
Up to 96 weeks (Weeks 24, 48, and 96)
ID
Title
Description
OG000
Belumosudil-R
Subjects randomized to treatment with belumosudil 400 mg orally once daily.
OG001
BSC-R
Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.
OG002
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
OG003
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
Secondary
Efficacy: Percentages of Subjects With Change From Baseline in DLCO (%) ≤ -15% at Weeks 24, 48, and 96
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%
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.
Posted
Count of Participants
Participants
Up to 96 weeks (Weeks 24, 48, and 96)
ID
Title
Description
OG000
Belumosudil-R
Subjects randomized to treatment with belumosudil 400 mg orally once daily.
OG001
BSC-R
Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.
OG002
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
Secondary
Efficacy: Mean Changes in Total Lung Fibrosis Score, by HRCT, From Baseline at Weeks 24, 48, and 96
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.
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.
Posted
Mean
Standard Deviation
score on a scale
Up to 96 weeks (Weeks 24, 48, and 96)
ID
Title
Description
OG000
Belumosudil-R
Subjects randomized to treatment with belumosudil 400 mg orally once daily.
OG001
BSC-R
Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.
OG002
Secondary
Efficacy: Categorical Changes in Lung Fibrosis as Observed by Sequential Scans of Radiologist Visual Assessment, From Baseline at Weeks 24, 48, and 96
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).
All randomized subjects.
Posted
Count of Participants
Participants
Up to 96 weeks (Weeks 24, 48, and 96)
ID
Title
Description
OG000
Belumosudil-R
Subjects randomized to treatment with belumosudil 400 mg orally once daily.
OG001
BSC-R
Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.
OG002
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
OG003
Secondary
Efficacy: Changes in Mean DTA Lung Fibrosis Score, by Radiologist Visual Assessment, From Baseline at Weeks 24, 48, and 96
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.
All randomized subjects
Posted
Mean
Standard Deviation
units on a scale (0-100)
Up to 96 Weeks (Weeks 24, 48, and 96)
ID
Title
Description
OG000
Belumosudil-R
Subjects randomized to treatment with belumosudil 400 mg orally once daily.
OG001
BSC-R
Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.
OG002
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
Secondary
Efficacy: Event-free Probability of Acute Exacerbation of IPF
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.
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.
Posted
Number
95% Confidence Interval
Event-free Probability
Up to 96 weeks (Weeks 24, 48, and 96)
ID
Title
Description
OG000
Belumosudil-R
Subjects randomized to treatment with belumosudil 400 mg orally once daily.
OG001
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
OG002
BSC-NC
Secondary
Efficacy: Event-free Probability of Progression of IPF
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.
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.
Posted
Number
95% Confidence Interval
Event-free Probability
Up to 96 weeks (Weeks 24, 48, and 96)
ID
Title
Description
OG000
Belumosudil-R
Subjects randomized to treatment with belumosudil 400 mg orally once daily.
OG001
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
OG002
BSC-NC
Secondary
Efficacy: Event-free Probability of First Respiratory-related Hospitalization
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.
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.
Posted
Number
95% Confidence Interval
Event-free Probability
Up to 96 weeks (Weeks 24, 48, and 96)
ID
Title
Description
OG000
Belumosudil-R
Subjects randomized to treatment with belumosudil 400 mg orally once daily.
OG001
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
Units
Counts
Participants
Secondary
Efficacy: Event-free Probability of Respiratory-related Death
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.
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.
Posted
Number
95% Confidence Interval
Event-free Probability
Up to 96 weeks (Weeks 24, 48, and 96)
ID
Title
Description
OG000
Belumosudil-R
Subjects randomized to treatment with belumosudil 400 mg orally once daily.
OG001
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
OG002
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
Secondary
Efficacy: Mean Changes in SGRQ From Baseline at Weeks 24, 48 and 96
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
All randomized subjects
Posted
Mean
Standard Deviation
units on a scale
Up to 96 weeks (Weeks 24, 48, and 96)
ID
Title
Description
OG000
Belumosudil-R
Subjects randomized to treatment with belumosudil 400 mg orally once daily.
OG001
BSC-R
Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.
OG002
Belumosudil-WC
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
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Belumosudil-R
Subjects randomized to treatment with belumosudil 400 mg orally once daily.
7
51
29
51
50
51
EG001
BSC-R
Subjects randomized to treatment with best supportive care (BSC) for 24 weeks.
3
24
10
24
23
24
EG002
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
9
68
38
68
67
68
EG003
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
1
24
4
24
19
24
EG004
Total
Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
10
75
39
75
73
75
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0006 affected51 at risk
EG0013 affected24 at risk
EG0028 affected68 at risk
EG0031 affected24 at risk
EG004
Dyspnea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0005 affected51 at risk
EG0011 affected24 at risk
EG0026 affected68 at risk
EG003
Pulmonary edema
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected24 at risk
EG0022 affected68 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0022 affected68 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected24 at risk
EG0021 affected68 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected24 at risk
EG0021 affected68 at risk
EG003
Chronic respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected24 at risk
EG0021 affected68 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected24 at risk
EG0021 affected68 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected24 at risk
EG0021 affected68 at risk
EG003
Congestive cardiac failure
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0003 affected51 at risk
EG0010 affected24 at risk
EG0023 affected68 at risk
EG003
Acute left ventricular failure
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Acute myocardial infarction (AMI)
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0012 affected24 at risk
EG0022 affected68 at risk
EG003
Anginal equivalent
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Aortic valve stenosis
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0012 affected24 at risk
EG0023 affected68 at risk
EG003
Complete atrioventricular block
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Cardiomyopathy
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0022 affected68 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected24 at risk
EG0021 affected68 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected24 at risk
EG0021 affected68 at risk
EG003
Myocardial infarction (MI)
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected24 at risk
EG0021 affected68 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0004 affected51 at risk
EG0010 affected24 at risk
EG0024 affected68 at risk
EG003
Corona virus infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Cystitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Influenza
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Pneumona influenzal
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Sepsis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected24 at risk
EG0021 affected68 at risk
EG003
Localized infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected24 at risk
EG0020 affected68 at risk
EG003
Viral pneumonia
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected24 at risk
EG0021 affected68 at risk
EG003
Chest pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Chills
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Pyrexia
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Melena
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0022 affected68 at risk
EG003
Retroperitoneal hemorrhage
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected24 at risk
EG0021 affected68 at risk
EG003
Basal ganglia hemorrhage
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Transient ischemic attack (TIA)
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected24 at risk
EG0021 affected68 at risk
EG003
Troponin increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Abnormal urine analysis
Investigations
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Metastatic lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Glomerulonephritis
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected24 at risk
EG0021 affected68 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Hypotension
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0022 affected68 at risk
EG003
Superficial thrombophlebitis
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected24 at risk
EG0020 affected68 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Hypovolemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected24 at risk
EG0021 affected68 at risk
EG003
Hyponatremia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected24 at risk
EG0021 affected68 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected24 at risk
EG0021 affected68 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected24 at risk
EG0021 affected68 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected24 at risk
EG0020 affected68 at risk
EG003
Toe amputation
Surgical and medical procedures
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected24 at risk
EG0021 affected68 at risk
EG003
Lung transplant
Surgical and medical procedures
MedDRA 20.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected24 at risk
EG0021 affected68 at risk
EG003
Amaurosis fugax
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected24 at risk
EG0021 affected68 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Dyspnea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG00019 affected51 at risk
EG0015 affected24 at risk
EG00221 affected68 at risk
EG0034 affected24 at risk
EG00424 affected75 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG00014 affected51 at risk
EG0018 affected24 at risk
EG00214 affected68 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0006 affected51 at risk
EG0013 affected24 at risk
EG0028 affected68 at risk
EG003
Exertional dyspnea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0003 affected51 at risk
EG0011 affected24 at risk
EG0023 affected68 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0003 affected51 at risk
EG0012 affected24 at risk
EG0024 affected68 at risk
EG003
Pulmonary mass
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0003 affected51 at risk
EG0012 affected24 at risk
EG0025 affected68 at risk
EG003
Pulmonary edema
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0003 affected51 at risk
EG0010 affected24 at risk
EG0023 affected68 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected24 at risk
EG0022 affected68 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0011 affected24 at risk
EG0023 affected68 at risk
EG003
Rales
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected24 at risk
EG0022 affected68 at risk
EG003
Upper airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0011 affected24 at risk
EG0023 affected68 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0022 affected68 at risk
EG003
Chronic respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0022 affected68 at risk
EG003
Lower respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0022 affected68 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0012 affected24 at risk
EG0022 affected68 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0022 affected68 at risk
EG003
Pulmonary congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0021 affected68 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0022 affected68 at risk
EG003
Sputum discolored
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0022 affected68 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0022 affected68 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0021 affected68 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0008 affected51 at risk
EG0015 affected24 at risk
EG00211 affected68 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0007 affected51 at risk
EG0015 affected24 at risk
EG0027 affected68 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0007 affected51 at risk
EG0010 affected24 at risk
EG0027 affected68 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0005 affected51 at risk
EG0016 affected24 at risk
EG0028 affected68 at risk
EG003
Viral gastroenteritis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0004 affected51 at risk
EG0010 affected24 at risk
EG0024 affected68 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0003 affected51 at risk
EG0010 affected24 at risk
EG0023 affected68 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0003 affected51 at risk
EG0010 affected24 at risk
EG0023 affected68 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0012 affected24 at risk
EG0024 affected68 at risk
EG003
Corona virus infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected24 at risk
EG0022 affected68 at risk
EG003
Influenza
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0011 affected24 at risk
EG0023 affected68 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0011 affected24 at risk
EG0023 affected68 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0011 affected24 at risk
EG0022 affected68 at risk
EG003
Viral infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected24 at risk
EG0022 affected68 at risk
EG003
Diarrhea
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG00012 affected51 at risk
EG0016 affected24 at risk
EG00218 affected68 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0006 affected51 at risk
EG0014 affected24 at risk
EG0028 affected68 at risk
EG003
Upper abdominal pain
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0003 affected51 at risk
EG0011 affected24 at risk
EG0024 affected68 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0003 affected51 at risk
EG0011 affected24 at risk
EG0024 affected68 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected24 at risk
EG0022 affected68 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected24 at risk
EG0022 affected68 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0011 affected24 at risk
EG0023 affected68 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0021 affected68 at risk
EG003
Gastroesophageal reflux disease (GERD)
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0021 affected68 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0022 affected68 at risk
EG003
Alanine aminotransferase (ALT) increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0008 affected51 at risk
EG0013 affected24 at risk
EG00210 affected68 at risk
EG003
Aspartate aminotransferase (AST) increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0006 affected51 at risk
EG0012 affected24 at risk
EG0028 affected68 at risk
EG003
Gamma-glutamyltransferase (GGT) increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0005 affected51 at risk
EG0013 affected24 at risk
EG0026 affected68 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0003 affected51 at risk
EG0011 affected24 at risk
EG0023 affected68 at risk
EG003
Prothrombin time prolonged
Investigations
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected24 at risk
EG0022 affected68 at risk
EG003
Weight decreased
Investigations
MedDRA 20.0
Systematic Assessment
EG0003 affected51 at risk
EG0010 affected24 at risk
EG0023 affected68 at risk
EG003
Weight increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected24 at risk
EG0022 affected68 at risk
EG003
Blood glucose increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0021 affected68 at risk
EG003
Blood lactate dehydrogenase (LDH) increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0021 affected68 at risk
EG003
Blood thyroid stimulating hormone (TSH) increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0013 affected24 at risk
EG0023 affected68 at risk
EG003
Blood urea increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0021 affected68 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0012 affected24 at risk
EG0023 affected68 at risk
EG003
Electrocardiogram (ECG) ST-segment abnormal
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 affected51 at risk
EG0012 affected24 at risk
EG0021 affected68 at risk
EG003
ECG T-wave abnormal
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 affected51 at risk
EG0012 affected24 at risk
EG0021 affected68 at risk
EG003
Fatigue
General disorders
MedDRA 20.0
Systematic Assessment
EG0007 affected51 at risk
EG0014 affected24 at risk
EG00211 affected68 at risk
EG003
Peripheral edema
General disorders
MedDRA 20.0
Systematic Assessment
EG0005 affected51 at risk
EG0011 affected24 at risk
EG0026 affected68 at risk
EG003
Chills
General disorders
MedDRA 20.0
Systematic Assessment
EG0004 affected51 at risk
EG0010 affected24 at risk
EG0024 affected68 at risk
EG003
Catheter site pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected24 at risk
EG0022 affected68 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0012 affected24 at risk
EG0022 affected68 at risk
EG003
Pyrexia
General disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected24 at risk
EG0022 affected68 at risk
EG003
Pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0022 affected68 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0005 affected51 at risk
EG0014 affected24 at risk
EG0027 affected68 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0004 affected51 at risk
EG0010 affected24 at risk
EG0024 affected68 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0004 affected51 at risk
EG0013 affected24 at risk
EG0025 affected68 at risk
EG003
Costcochondritis
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0003 affected51 at risk
EG0010 affected24 at risk
EG0023 affected68 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0003 affected51 at risk
EG0011 affected24 at risk
EG0023 affected68 at risk
EG003
Clubbing
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected24 at risk
EG0022 affected68 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected24 at risk
EG0022 affected68 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected24 at risk
EG0022 affected68 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected24 at risk
EG0022 affected68 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected24 at risk
EG0022 affected68 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0022 affected68 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0012 affected24 at risk
EG0023 affected68 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0006 affected51 at risk
EG0012 affected24 at risk
EG0027 affected68 at risk
EG003
Headache
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0004 affected51 at risk
EG0011 affected24 at risk
EG0024 affected68 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0004 affected51 at risk
EG0010 affected24 at risk
EG0024 affected68 at risk
EG003
Hypoesthesia
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected24 at risk
EG0022 affected68 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected24 at risk
EG0022 affected68 at risk
EG003
Paresthesia
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0011 affected24 at risk
EG0023 affected68 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0022 affected68 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0004 affected51 at risk
EG0011 affected24 at risk
EG0025 affected68 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0003 affected51 at risk
EG0012 affected24 at risk
EG0025 affected68 at risk
EG003
Congestive cardiac failure
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0003 affected51 at risk
EG0011 affected24 at risk
EG0024 affected68 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0012 affected24 at risk
EG0024 affected68 at risk
EG003
Acute myocardial infarction (AMI)
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0012 affected24 at risk
EG0022 affected68 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0022 affected68 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0004 affected51 at risk
EG0011 affected24 at risk
EG0024 affected68 at risk
EG003
Stress fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected24 at risk
EG0022 affected68 at risk
EG003
Head injuries
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0022 affected68 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0022 affected68 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0022 affected68 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0022 affected68 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0022 affected68 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0006 affected51 at risk
EG0011 affected24 at risk
EG0027 affected68 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0004 affected51 at risk
EG0011 affected24 at risk
EG0025 affected68 at risk
EG003
Depression
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0003 affected51 at risk
EG0010 affected24 at risk
EG0023 affected68 at risk
EG003
Panic attack
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0021 affected68 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0005 affected51 at risk
EG0010 affected24 at risk
EG0025 affected68 at risk
EG003
Hyperglycemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0011 affected24 at risk
EG0023 affected68 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0022 affected68 at risk
EG003
Hyponatremia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0022 affected68 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0022 affected68 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected24 at risk
EG0022 affected68 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected24 at risk
EG0022 affected68 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0011 affected24 at risk
EG0023 affected68 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected24 at risk
EG0022 affected68 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected51 at risk
EG0013 affected24 at risk
EG0022 affected68 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0003 affected51 at risk
EG0010 affected24 at risk
EG0023 affected68 at risk
EG003
Anemia
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0011 affected24 at risk
EG0022 affected68 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected24 at risk
EG0022 affected68 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0003 affected51 at risk
EG0010 affected24 at risk
EG0023 affected68 at risk
EG003
Hypertension
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected24 at risk
EG0022 affected68 at risk
EG003
Hypotension
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0011 affected24 at risk
EG0023 affected68 at risk
EG003
Hematuria
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0021 affected68 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected24 at risk
EG0022 affected68 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0022 affected68 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0022 affected68 at risk
EG003
Vision blurred
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected24 at risk
EG0022 affected68 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0022 affected68 at risk
EG003
Small intestinal obstruction
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0022 affected68 at risk
EG003
Syncope
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected24 at risk
EG0021 affected68 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Karin Herrera, Vice President, Clinical Operations
Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Units
Counts
Participants
OG00052
OG00124
OG00269
OG00324
OG00476
Title
Denominators
Categories
Baseline
ParticipantsOG00052
ParticipantsOG00124
ParticipantsOG00264
ParticipantsOG00324
ParticipantsOG00476
Title
Measurements
OG00069.61± 18.07
OG00168.46± 15.63
OG00269.73± 17.70
OG003
At Week 24
ParticipantsOG00038
ParticipantsOG00121
ParticipantsOG00246
ParticipantsOG00319
Change at Week 24
ParticipantsOG00038
ParticipantsOG00121
ParticipantsOG00246
ParticipantsOG00319
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
OG004
Total
Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Units
Counts
Participants
OG00051
OG00124
OG00268
OG00324
OG00475
Title
Denominators
Categories
TEAEs Related to Treatment (All Grades)
Title
Measurements
OG00023
OG0019
OG00232
OG0032
OG00432
TEAEs Related to Treatment (Only Grades 3 & 4)
Title
Measurements
OG0002
OG0010
OG0022
OG003
OG004
Total
Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Units
Counts
Participants
OG00051
OG00124
OG00268
OG00324
OG00475
Title
Denominators
Categories
Title
Measurements
OG0002
OG0010
OG0022
OG0030
OG0042
Total
Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Units
Counts
Participants
OG00051
OG00124
OG00268
OG00375
Title
Denominators
Categories
All TEAEs Leading to Discontinuation
Title
Measurements
OG00014
OG0018
OG00222
OG00322
TEAEs Related to Belumosudil Leading to Study Discontinuation
Title
Measurements
OG0005
OG0011
OG0026
OG003
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
OG004
Total
Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Units
Counts
Participants
OG00051
OG00124
OG00268
OG00319
OG00475
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
Units
Counts
Participants
OG00058
OG00121
Title
Denominators
Categories
GAP Stage I
ParticipantsOG00013
ParticipantsOG0017
Title
Measurements
OG000-117.65(-324.28 to 88.98)
OG001-156.50(-355.39 to 42.40)
GAP Stage II
ParticipantsOG00026
ParticipantsOG0019
Title
Measurements
OG000-219.90(-416.20 to -23.60)
OG001
GAP Stage III
ParticipantsOG0007
ParticipantsOG0013
Title
Measurements
OG000101.95(-1246.61 to 1450.50)
OG001
No Prior Use of Pirfenidone or Nintedanib
ParticipantsOG00034
ParticipantsOG00116
Title
Measurements
OG000-80.34(-190.81 to 30.14)
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
GAP Stage I-- Difference: Belumosudil-WC minus BSC-NC = 38.85 (95% CI: -126.99, 204.69) mL
Mixed Models Analysis
Results are not stable due to small sample size and signal/noise ratio
0.5733
Superiority
OG000
OG001
GAP Stage II-- Difference: Belumosudil-WC minus BSC-NC = -39.96 (95% CI: -288.63, 208.71) mL
Mixed Models Analysis
Results are not stable due to small sample size and signal/noise ratio
0.6967
Superiority
OG000
OG001
GAP Stage III-- Difference: Belumosudil-WC minus BSC-NC = 94.16 (95% CI: -1103.56, 1291.88) mL
Mixed Models Analysis
Results are not stable due to small sample size and signal/noise ratio
0.5003
Superiority
OG000
OG001
No Prior Pirfenidone or Nintedanib-- Difference: Belumosudil-WC minus BSC-NC = -34.13 (95% CI: -137.08, 68.82)
Mixed Models Analysis
Results are not stable due to small sample size and signal/noise ratio
0.4866
Superiority
Units
Counts
Participants
OG00052
OG00124
OG00269
OG00376
Title
Denominators
Categories
Baseline
ParticipantsOG00052
ParticipantsOG00124
ParticipantsOG00264
ParticipantsOG00376
Title
Measurements
OG0002608.2± 829.6
OG0012516.7± 741.8
OG0022608.8± 840.4
OG003
Change at Week 48
ParticipantsOG00029
ParticipantsOG0018
ParticipantsOG00235
ParticipantsOG00337
Change at Week 96
ParticipantsOG00020
ParticipantsOG0015
ParticipantsOG00223
ParticipantsOG00325
Change at EOT
ParticipantsOG00021
ParticipantsOG0017
ParticipantsOG00227
ParticipantsOG00328
OG004
Total
Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Units
Counts
Participants
OG00052
OG00124
OG00269
OG00324
OG00476
Title
Denominators
Categories
Baseline
ParticipantsOG00052
ParticipantsOG00124
ParticipantsOG00264
ParticipantsOG00324
ParticipantsOG00476
Title
Measurements
OG0000.829± 0.0613
OG0010.816± 0.0674
OG0020.832± 0.0584
OG003
Change at Week 24
ParticipantsOG00038
ParticipantsOG00121
ParticipantsOG00246
ParticipantsOG00319
Change at Week 48
ParticipantsOG00029
ParticipantsOG0018
ParticipantsOG00235
ParticipantsOG0030
Change at Week 96
ParticipantsOG00020
ParticipantsOG0015
ParticipantsOG00223
ParticipantsOG0030
Change at EOT
ParticipantsOG00021
ParticipantsOG0017
ParticipantsOG00227
ParticipantsOG0031
Units
Counts
Participants
OG00058
OG00121
Title
Denominators
Categories
GAP Stage I
ParticipantsOG00013
ParticipantsOG0017
Title
Measurements
OG000-4.65(-11.34 to 2.03)
OG001-6.53(-13.14 to 0.07)
GAP Stage II
ParticipantsOG00026
ParticipantsOG0019
Title
Measurements
OG000-6.42(-11.69 to -1.15)
OG001
GAP Stage III
ParticipantsOG0007
ParticipantsOG0013
Title
Measurements
OG0002.34(-36.32 to 40.99)
OG001
Prior Use of Pirfenidone or Nintedanib
ParticipantsOG00012
ParticipantsOG0013
Title
Measurements
OG000-6.20(-58.23 to 45.82)
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
Results are not stable due to small sample size and signal/noise ratio
0.3391
Superiority
GAP Stage I-- Difference: Belumosudil-WC minus BSC-NC = 1.88 (95% CI: -2.69, 6.45)
OG000
OG001
Mixed Models Analysis
Results are not stable due to small sample size and signal/noise ratio
0.5201
Superiority
GAP Stage II-- Difference: Belumosudil-WC minus BSC-NC = -1.72 (95% CI: -8.13, 4.69)
OG000
OG001
Mixed Models Analysis
Results are not stable due to small sample size and signal/noise ratio
0.4426
Superiority
GAP Stage III-- Difference: Belumosudil-WC minus BSC-NC = 2.48 (95% CI: -23.84, 28.81)
OG000
OG001
Mixed Models Analysis
Results are not stable due to small sample size and signal/noise ratio
0.4260
Superiority
No Prior Use of Pirfenidone or Nintedanib-- Difference: Belumosudil-WC minus BSC-NC = 8.70 (95% CI: -78.76, -96.17)
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
OG004
Total
Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Units
Counts
Participants
OG00046
OG00124
OG00258
OG00321
OG00470
Title
Denominators
Categories
At Week 24: Yes
ParticipantsOG00038
ParticipantsOG00121
ParticipantsOG00246
ParticipantsOG00319
ParticipantsOG00459
Title
Measurements
OG00011
OG0017
OG00214
OG003
At Week 24: No
ParticipantsOG00038
ParticipantsOG00121
ParticipantsOG00246
ParticipantsOG00319
At Week 48: Yes
ParticipantsOG00029
ParticipantsOG0018
ParticipantsOG00235
ParticipantsOG0030
At Week 48: No
ParticipantsOG00029
ParticipantsOG0018
ParticipantsOG00235
ParticipantsOG0030
At Week 96: Yes
ParticipantsOG00020
ParticipantsOG0015
ParticipantsOG00223
ParticipantsOG0030
At Week 96: No
ParticipantsOG00020
ParticipantsOG0015
ParticipantsOG00223
ParticipantsOG0030
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
OG004
Total
Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Units
Counts
Participants
OG00046
OG00124
OG00258
OG00321
OG00470
Title
Denominators
Categories
At Week 24: Yes
ParticipantsOG00038
ParticipantsOG00121
ParticipantsOG00246
ParticipantsOG00319
ParticipantsOG00459
Title
Measurements
OG0005
OG0014
OG0026
OG003
At Week 24: No
ParticipantsOG00038
ParticipantsOG00121
ParticipantsOG00246
ParticipantsOG00319
At Week 48: Yes
ParticipantsOG00029
ParticipantsOG0018
ParticipantsOG00235
ParticipantsOG0030
At Week 48: No
ParticipantsOG00029
ParticipantsOG0018
ParticipantsOG00235
ParticipantsOG0030
At Week 96: Yes
ParticipantsOG00020
ParticipantsOG0015
ParticipantsOG00223
ParticipantsOG0030
At Week 96: No
ParticipantsOG00020
ParticipantsOG0015
ParticipantsOG00223
ParticipantsOG0030
OG004
Total
Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Units
Counts
Participants
OG00052
OG00124
OG00269
OG00324
OG00476
Title
Denominators
Categories
Baseline
ParticipantsOG00051
ParticipantsOG00124
ParticipantsOG00265
ParticipantsOG00319
ParticipantsOG00475
Title
Measurements
OG000368.59± 168.84
OG001349.25± 180.40
OG002350.12± 168.88
OG003
Change at Week 24
ParticipantsOG00037
ParticipantsOG00120
ParticipantsOG00245
ParticipantsOG00313
Change at Week 48
ParticipantsOG00030
ParticipantsOG0018
ParticipantsOG00236
ParticipantsOG0030
Change at Week 96
ParticipantsOG00017
ParticipantsOG0015
ParticipantsOG00220
ParticipantsOG0030
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
OG004
Total
Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Units
Counts
Participants
OG00046
OG00124
OG00258
OG00321
OG00470
Title
Denominators
Categories
≥ 50 Meter Improvement at Week 24: Yes
ParticipantsOG00037
ParticipantsOG00120
ParticipantsOG00245
ParticipantsOG00313
ParticipantsOG00457
Title
Measurements
OG0006
OG0014
OG0028
OG003
≥ 50 Meter Improvement at Week 24: No
ParticipantsOG00037
ParticipantsOG00120
ParticipantsOG00245
ParticipantsOG00313
≥ 50 Meter Improvement at Week 48: Yes
ParticipantsOG00030
ParticipantsOG0018
ParticipantsOG00236
ParticipantsOG0030
≥ 50 Meter Improvement at Week 48: No
ParticipantsOG00030
ParticipantsOG0018
ParticipantsOG00236
ParticipantsOG0030
≥ 50 Meter Improvement at Week 96: Yes
ParticipantsOG00017
ParticipantsOG0015
ParticipantsOG00220
ParticipantsOG0030
≥ 50 Meter Improvement at Week 96: No
ParticipantsOG00017
ParticipantsOG0015
ParticipantsOG00220
ParticipantsOG0030
OG004
Total
Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Units
Counts
Participants
OG00052
OG00124
OG00269
OG00324
OG00476
Title
Denominators
Categories
Baseline
ParticipantsOG00051
ParticipantsOG00124
ParticipantsOG00263
ParticipantsOG00319
ParticipantsOG00475
Title
Measurements
OG00047.3± 11.7
OG00147.3± 9.9
OG00247.1± 12.0
OG003
Change at Week 24
ParticipantsOG00035
ParticipantsOG00121
ParticipantsOG00242
ParticipantsOG00315
Change at Week 48
ParticipantsOG00028
ParticipantsOG0018
ParticipantsOG00234
ParticipantsOG0030
Change at Week 96
ParticipantsOG00010
ParticipantsOG0015
ParticipantsOG00213
ParticipantsOG0030
OG003
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
OG004
Total
Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Units
Counts
Participants
OG00046
OG00124
OG00258
OG00321
OG00470
Title
Denominators
Categories
Week 24 Change ≤ -15%: Yes
ParticipantsOG00036
ParticipantsOG00121
ParticipantsOG00243
ParticipantsOG00315
ParticipantsOG00457
Title
Measurements
OG0007
OG0017
OG00210
OG003
Week 24 Change ≤ -15%: No
ParticipantsOG00036
ParticipantsOG00121
ParticipantsOG00243
ParticipantsOG00315
Week 48 Change ≤ -15%: Yes
ParticipantsOG00028
ParticipantsOG0018
ParticipantsOG00234
ParticipantsOG0030
Week 48 Change ≤ -15%: No
ParticipantsOG00028
ParticipantsOG0018
ParticipantsOG00234
ParticipantsOG0030
Week 96 Change ≤ -15%: Yes
ParticipantsOG00010
ParticipantsOG0015
ParticipantsOG00213
ParticipantsOG0030
Week 96 Change ≤ -15%: No
ParticipantsOG00010
ParticipantsOG0015
ParticipantsOG00213
ParticipantsOG0030
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
OG003
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
OG004
Total
Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Units
Counts
Participants
OG00052
OG00124
OG00269
OG00324
OG00476
Title
Denominators
Categories
Baseline
ParticipantsOG00043
ParticipantsOG00121
ParticipantsOG00245
ParticipantsOG00321
ParticipantsOG00464
Title
Measurements
OG00030.91± 14.54
OG00133.34± 17.81
OG00231.78± 15.48
OG003
Change at Week 24
ParticipantsOG00032
ParticipantsOG00117
ParticipantsOG00234
ParticipantsOG00316
Change at Week 48
ParticipantsOG00022
ParticipantsOG0017
ParticipantsOG00223
ParticipantsOG0030
Change at Week 96
ParticipantsOG00015
ParticipantsOG0013
ParticipantsOG00215
ParticipantsOG0030
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
OG004
Total
Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Units
Counts
Participants
OG00046
OG00124
OG00258
OG00321
OG00470
Title
Denominators
Categories
Week 24: Better
ParticipantsOG00035
ParticipantsOG00118
ParticipantsOG00243
ParticipantsOG00316
ParticipantsOG00453
Title
Measurements
OG0000
OG0011
OG0021
OG003
Week 24: Same
ParticipantsOG00035
ParticipantsOG00118
ParticipantsOG00243
ParticipantsOG00316
Week 24: Worse
ParticipantsOG00035
ParticipantsOG00118
ParticipantsOG00243
ParticipantsOG00316
Week 48: Better
ParticipantsOG00016
ParticipantsOG0017
ParticipantsOG00220
ParticipantsOG0030
Week 48: Same
ParticipantsOG00016
ParticipantsOG0017
ParticipantsOG00220
ParticipantsOG0030
Week 48: Worse
ParticipantsOG00016
ParticipantsOG0017
ParticipantsOG00220
ParticipantsOG0030
Week 96: Better
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0025
ParticipantsOG0030
Week 96: Same
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0025
ParticipantsOG0030
Week 96: Worse
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0025
ParticipantsOG0030
OG003
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
OG004
Total
Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC
Units
Counts
Participants
OG00052
OG00124
OG00269
OG00324
OG00476
Title
Denominators
Categories
Baseline
ParticipantsOG00042
ParticipantsOG00122
ParticipantsOG00248
ParticipantsOG00322
ParticipantsOG00465
Title
Measurements
OG00023.1± 11.99
OG00122.7± 10.77
OG00222.3± 12.07
OG003
Change at Week 24
ParticipantsOG00031
ParticipantsOG00117
ParticipantsOG00234
ParticipantsOG00316
Change at Week 48
ParticipantsOG00013
ParticipantsOG0017
ParticipantsOG00214
ParticipantsOG0030
Change at Week 96
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0030
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
Units
Counts
Participants
OG00046
OG00158
OG00221
Title
Denominators
Categories
24 weeks
ParticipantsOG00046
ParticipantsOG00158
ParticipantsOG00221
Title
Measurements
OG0000.91(0.78 to 0.97)
OG0010.91(0.80 to 0.96)
OG0020.92(0.54 to 0.99)
48 weeks
ParticipantsOG00046
ParticipantsOG00158
ParticipantsOG0020
Title
Measurements
OG000
96 weeks
ParticipantsOG00046
ParticipantsOG00158
ParticipantsOG0020
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Hazard ratio: 0.86 (0.16, 4.48)
Log Rank
0.8561
2-Sided
95
Superiority
Cox Regression
OG001
OG002
Hazard ratio: 0.87 (95% CI: 0.17, 4.33)
Log Rank
0.8608
2-Sided
95
Superiority
Cox Regression
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
Units
Counts
Participants
OG00046
OG00158
OG00221
Title
Denominators
Categories
24 weeks
ParticipantsOG00046
ParticipantsOG00158
ParticipantsOG00221
Title
Measurements
OG0000.86(0.71 to 0.93)
OG0010.80(0.67 to 0.88)
OG0020.66(0.39 to 0.83)
48 weeks
ParticipantsOG00046
ParticipantsOG00158
ParticipantsOG0020
Title
Measurements
OG000
96 weeks
ParticipantsOG00046
ParticipantsOG00158
ParticipantsOG0020
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Hazard ratio: 0.34 (95% CI: 0.14, 0.79)
Log Rank
0.0084
2-Sided
95
Superiority
Cox Regression
OG001
OG002
Hazard Ratio: 0.47 (95% CI: 0.22, 1.03)
Log Rank
0.0508
2-Sided
95
Superiority
Cox Regression
OG00046
OG00158
Title
Denominators
Categories
24 weeks
Title
Measurements
OG0000.98(0.85 to 1.00)
OG0010.96(0.86 to 0.99)
48 weeks
Title
Measurements
OG0000.89(0.74 to 0.96)
OG0010.85(0.72 to 0.93)
96 weeks
Title
Measurements
OG0000.79(0.61 to 0.90)
OG0010.75(0.58 to 0.85)
Units
Counts
Participants
OG00046
OG00158
OG00221
Title
Denominators
Categories
24 weeks
ParticipantsOG00046
ParticipantsOG00158
ParticipantsOG00221
Title
Measurements
OG0000.98(0.85 to 1.00)
OG0010.98(0.87 to 1.00)
OG0020.95(0.69 to 0.99)
48 weeks
ParticipantsOG00046
ParticipantsOG00158
ParticipantsOG0020
Title
Measurements
OG000
96 weeks
ParticipantsOG00046
ParticipantsOG00158
ParticipantsOG0020
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Hazard ratio: 0.34 (95% CI: 0.02, 5.54)
Log Rank
0.4251
2-Sided
95
Superiority
Cox Regression
OG001
OG002
Hazard ratio: 0.27 (95% CI: 0.02, 4.45)
Log Rank
0.3294
2-Sided
95
Superiority
Cox Regression
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
OG003
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
OG004
Total
Subjects randomized to belumosudil 400 mg PO QD plus those randomized to BSC