Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Chronic Graft Versus Host Disease (NCT NCT02841995)
NCT ID: NCT02841995
Last Updated: 2023-06-28
Results Overview
OR was defined as the percentage of participants with complete response (CR) or partial response (PR). The OR determination of chronic graft versus host disease (cGVHD) was based on cGVHD response assessment performed by clinicians as per the 2014 National Institutes of Health (NIH) Consensus Development Project for Clinical Trials in cGVHD criteria. CR was defined as the resolution of all manifestations in each organ or site. PR was defined as the improvement in at least 1 organ or site without progression in any other organ or site; and cGVHD progression was defined as the clinically meaningful worsening in 1 or more organs regardless of improvement in other organs.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
From the date of randomization to the date of first documentation of progression or death due to any cause or data cut-off, whichever occurred first (maximum duration: up to 64.2 months)
Results posted on
2023-06-28
Participant Flow
The study was conducted at 7 active sites in the United States. A total of 64 participants were screened between 15 September 2016 and 08 March 2018, of which 10 participants were screen failures due to not meeting eligibility criteria.
A total of 54 participants were enrolled and treated with belumosudil in the study.
Participant milestones
| Measure |
Cohort 1: Belumosudil 200 mg QD
Participants received belumosudil 200 milligrams (mg) orally once daily (QD) in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 64.2 months).
|
Cohort 2: Belumosudil 200 mg BID
Participants received belumosudil 200 mg orally twice daily (BID) in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 45.9 months).
|
Cohort 3: Belumosudil 400 mg QD
Participants received belumosudil 400 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 49.2 months).
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
21
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
17
|
16
|
21
|
Reasons for withdrawal
| Measure |
Cohort 1: Belumosudil 200 mg QD
Participants received belumosudil 200 milligrams (mg) orally once daily (QD) in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 64.2 months).
|
Cohort 2: Belumosudil 200 mg BID
Participants received belumosudil 200 mg orally twice daily (BID) in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 45.9 months).
|
Cohort 3: Belumosudil 400 mg QD
Participants received belumosudil 400 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 49.2 months).
|
|---|---|---|---|
|
Overall Study
Disease progression
|
5
|
11
|
8
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
4
|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
|
Overall Study
Investigator decision
|
2
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
2
|
|
Overall Study
Noncompliance to protocol
|
1
|
0
|
0
|
|
Overall Study
Sponsor decision
|
1
|
0
|
0
|
|
Overall Study
Other
|
4
|
1
|
5
|
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Chronic Graft Versus Host Disease
Baseline characteristics by cohort
| Measure |
Cohort 1: Belumosudil 200 mg QD
n=17 Participants
Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 64.2 months).
|
Cohort 2: Belumosudil 200 mg BID
n=16 Participants
Participants received belumosudil 200 mg orally BID in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 45.9 months).
|
Cohort 3: Belumosudil 400 mg QD
n=21 Participants
Participants received belumosudil 400 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 49.2 months).
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.0 years
n=5 Participants
|
55.0 years
n=7 Participants
|
46.0 years
n=5 Participants
|
51.5 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From the date of randomization to the date of first documentation of progression or death due to any cause or data cut-off, whichever occurred first (maximum duration: up to 64.2 months)Population: Analysis was performed on mITT population.
OR was defined as the percentage of participants with complete response (CR) or partial response (PR). The OR determination of chronic graft versus host disease (cGVHD) was based on cGVHD response assessment performed by clinicians as per the 2014 National Institutes of Health (NIH) Consensus Development Project for Clinical Trials in cGVHD criteria. CR was defined as the resolution of all manifestations in each organ or site. PR was defined as the improvement in at least 1 organ or site without progression in any other organ or site; and cGVHD progression was defined as the clinically meaningful worsening in 1 or more organs regardless of improvement in other organs.
Outcome measures
| Measure |
Cohort 1: Belumosudil 200 mg QD
n=17 Participants
Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 64.2 months).
|
Cohort 2: Belumosudil 200 mg BID
n=16 Participants
Participants received belumosudil 200 mg orally BID in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 45.9 months).
|
Cohort 3: Belumosudil 400 mg QD
n=21 Participants
Participants received belumosudil 400 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 49.2 months).
|
|---|---|---|---|
|
Percentage of Participants With Overall Response (OR)
|
64.7 percentage of participants
Interval 38.3 to 85.8
|
68.8 percentage of participants
Interval 41.3 to 89.0
|
57.1 percentage of participants
Interval 34.0 to 78.2
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)Population: Analysis was performed on safety population which included all participants who received at least 1 dose of study medication.
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Serious adverse events (SAEs) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the TEAE period (defined as the time from the first dose of study drug up to 28 days after the last dose of study drug). TEAEs included both SAEs and non-SAEs.
Outcome measures
| Measure |
Cohort 1: Belumosudil 200 mg QD
n=17 Participants
Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 64.2 months).
|
Cohort 2: Belumosudil 200 mg BID
n=16 Participants
Participants received belumosudil 200 mg orally BID in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 45.9 months).
|
Cohort 3: Belumosudil 400 mg QD
n=21 Participants
Participants received belumosudil 400 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 49.2 months).
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), and Treatment-emergent Serious Adverse Events (TESAEs)
TEAE
|
17 Participants
|
16 Participants
|
20 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), and Treatment-emergent Serious Adverse Events (TESAEs)
TESAE
|
5 Participants
|
6 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: From the date of randomization to the date of first documentation of progression or death due to any cause or data cut-off, whichever occurred first (maximum duration: up to 64.2 months)Population: Analysis was performed on mITT population.
BOR was defined as the participants with either a CR or PR or lack of response (LOR), where LOR included the response status of unchanged (LOR-U), mixed (LOR-M), or progression (LOR-P). BOR was assessed per the 2014 NIH Consensus Development Project for Clinical Trials in cGVHD criteria. CR was defined as the resolution of all manifestations in each organ or site; PR was defined as the improvement in at least 1 organ or site without progression in any other organ or site; LOR-M was defined as CR or PR in at least one organ accompanied by progression in another organ, LOR-U was defined as outcomes that did not meet the criteria for CR, PR, progression or mixed response, LOR-P was defined as progression in at least one organ or site without a response in any other organ or site.
Outcome measures
| Measure |
Cohort 1: Belumosudil 200 mg QD
n=17 Participants
Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 64.2 months).
|
Cohort 2: Belumosudil 200 mg BID
n=16 Participants
Participants received belumosudil 200 mg orally BID in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 45.9 months).
|
Cohort 3: Belumosudil 400 mg QD
n=21 Participants
Participants received belumosudil 400 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 49.2 months).
|
|---|---|---|---|
|
Number of Participants With Best Overall Response (BOR)
CR
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Best Overall Response (BOR)
PR
|
11 Participants
|
11 Participants
|
12 Participants
|
|
Number of Participants With Best Overall Response (BOR)
LOR-U
|
2 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Best Overall Response (BOR)
LOR-M
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Best Overall Response (BOR)
LOR-P
|
2 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Baseline up to end of treatment (i.e., up to 64.2 months)Population: Analysis was performed on mITT population.
The GSR assessment was performed by asking the participants to rate their disease severity of cGVHD symptoms on a 0 to 10-point numeric rating scale, where score 0 indicated 'not at all severe cGVHD symptoms' and score 10 indicated 'most severe cGVHD symptoms possible'. The response was defined using scores from 9 organs: skin, eyes, mouth, esophagus, upper gastrointestinal (GI) track, lower GI tract, liver, lungs, and joints and fascia plus GSR. End of treatment (EOT) visit was performed within 3 days after participant's last dose of study drug. Baseline value was defined as valid and last non-missing value obtained within 28 days prior to participant receiving first study medication. Maximal improvement from Baseline was calculated as lowest GSR score on scheduled visits minus GSR score at Baseline with possible ranges from -10 to 10. The lower the number means the better improvement in cGVHD symptoms. Only those categories in which at least 1 participant had data were reported.
Outcome measures
| Measure |
Cohort 1: Belumosudil 200 mg QD
n=17 Participants
Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 64.2 months).
|
Cohort 2: Belumosudil 200 mg BID
n=16 Participants
Participants received belumosudil 200 mg orally BID in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 45.9 months).
|
Cohort 3: Belumosudil 400 mg QD
n=21 Participants
Participants received belumosudil 400 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 49.2 months).
|
|---|---|---|---|
|
Number of Participants With Maximal Improvement From Baseline in Global Severity Rating (GSR) by Clinician-reported cGVHD Assessment
-7
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Maximal Improvement From Baseline in Global Severity Rating (GSR) by Clinician-reported cGVHD Assessment
-6
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Maximal Improvement From Baseline in Global Severity Rating (GSR) by Clinician-reported cGVHD Assessment
-5
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Maximal Improvement From Baseline in Global Severity Rating (GSR) by Clinician-reported cGVHD Assessment
-4
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Maximal Improvement From Baseline in Global Severity Rating (GSR) by Clinician-reported cGVHD Assessment
-3
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximal Improvement From Baseline in Global Severity Rating (GSR) by Clinician-reported cGVHD Assessment
-2
|
2 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Maximal Improvement From Baseline in Global Severity Rating (GSR) by Clinician-reported cGVHD Assessment
-1
|
1 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Maximal Improvement From Baseline in Global Severity Rating (GSR) by Clinician-reported cGVHD Assessment
0
|
5 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Maximal Improvement From Baseline in Global Severity Rating (GSR) by Clinician-reported cGVHD Assessment
1
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Maximal Improvement From Baseline in Global Severity Rating (GSR) by Clinician-reported cGVHD Assessment
3
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximal Improvement From Baseline in Global Severity Rating (GSR) by Clinician-reported cGVHD Assessment
Missing
|
1 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From Baseline up to end of treatment (i.e., up to 64.2 months)Population: Analysis was performed on mITT population. Only those categories in which at least 1 participant had data were reported.
cGVHD symptom severity was self-reported by participants. Participants were asked to rate their disease symptom severity over the last week on the following questions: skin itching at its worst, moth dryness at its worst, mouth pain at its worst, mouth sensitivity at its worst, main compliant on eyes, symptom severity on eyes. Severity rating was done on a 0 to 10-point numeric rating scare, where score 0 indicated 'not at all severe cGVHD symptoms' and score 10 indicated 'most severe cGVHD symptoms possible'. EOT visit was performed within 3 days after participant's last dose of study drug. Baseline value was defined as valid and last non-missing value obtained within 28 days prior to participant receiving first study medication. Maximal improvement from Baseline was calculated as the lowest symptom severity score on scheduled visits minus the symptom severity score at Baseline with possible ranges from -10 to 10. The lower the number means the better improvement in cGVHD symptoms.
Outcome measures
| Measure |
Cohort 1: Belumosudil 200 mg QD
n=17 Participants
Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 64.2 months).
|
Cohort 2: Belumosudil 200 mg BID
n=16 Participants
Participants received belumosudil 200 mg orally BID in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 45.9 months).
|
Cohort 3: Belumosudil 400 mg QD
n=21 Participants
Participants received belumosudil 400 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 49.2 months).
|
|---|---|---|---|
|
Number of Participants With Maximal Improvement From Baseline in Symptom Activity by cGVHD Activity Assessment Participant Self-Report
-8
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximal Improvement From Baseline in Symptom Activity by cGVHD Activity Assessment Participant Self-Report
-7
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Maximal Improvement From Baseline in Symptom Activity by cGVHD Activity Assessment Participant Self-Report
-6
|
0 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Maximal Improvement From Baseline in Symptom Activity by cGVHD Activity Assessment Participant Self-Report
-5
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Maximal Improvement From Baseline in Symptom Activity by cGVHD Activity Assessment Participant Self-Report
-4
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Maximal Improvement From Baseline in Symptom Activity by cGVHD Activity Assessment Participant Self-Report
-3
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Maximal Improvement From Baseline in Symptom Activity by cGVHD Activity Assessment Participant Self-Report
-2
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Maximal Improvement From Baseline in Symptom Activity by cGVHD Activity Assessment Participant Self-Report
-1
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Maximal Improvement From Baseline in Symptom Activity by cGVHD Activity Assessment Participant Self-Report
0
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximal Improvement From Baseline in Symptom Activity by cGVHD Activity Assessment Participant Self-Report
1
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximal Improvement From Baseline in Symptom Activity by cGVHD Activity Assessment Participant Self-Report
2
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Maximal Improvement From Baseline in Symptom Activity by cGVHD Activity Assessment Participant Self-Report
4
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximal Improvement From Baseline in Symptom Activity by cGVHD Activity Assessment Participant Self-Report
Missing
|
2 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug to either start of another new systemic treatment for cGVHD, relapse of the underlying disease or death or data cut-off, whichever occurred first (maximum duration: up to 64.2 months)Population: Analysis was performed on mITT population.
Failure-free survival was defined as the time (in months) from first dose of study drug to either the start of another new systemic treatment for cGVHD, relapse of the underlying disease or death. If no such events happened, FFS was censored by last response assessment or long term follow up assessment, whichever was the latest and available. Kaplan-Meier survival method was used for the analysis.
Outcome measures
| Measure |
Cohort 1: Belumosudil 200 mg QD
n=17 Participants
Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 64.2 months).
|
Cohort 2: Belumosudil 200 mg BID
n=16 Participants
Participants received belumosudil 200 mg orally BID in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 45.9 months).
|
Cohort 3: Belumosudil 400 mg QD
n=21 Participants
Participants received belumosudil 400 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 49.2 months).
|
|---|---|---|---|
|
Failure-free Survival (FFS)
|
10.6 months
Interval 3.78 to
95% confidence interval (CI) upper limit was not available because of the less number of participants with event.
|
9.8 months
Interval 4.01 to 19.02
|
9.7 months
Interval 2.6 to 16.1
|
SECONDARY outcome
Timeframe: Baseline up to end of treatment (i.e., anytime up to 64.2 months)Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
Baseline value was defined as valid and last non-missing value obtained within 28 days prior to participant receiving first study medication. EOT visit was performed within 3 days after the participant's last dose of study drug.
Outcome measures
| Measure |
Cohort 1: Belumosudil 200 mg QD
n=17 Participants
Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 64.2 months).
|
Cohort 2: Belumosudil 200 mg BID
n=15 Participants
Participants received belumosudil 200 mg orally BID in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 45.9 months).
|
Cohort 3: Belumosudil 400 mg QD
n=19 Participants
Participants received belumosudil 400 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 49.2 months).
|
|---|---|---|---|
|
Change From Baseline in Corticosteroids Dose
|
-0.110 milligrams per kilogram per day
Standard Deviation 0.101
|
-0.111 milligrams per kilogram per day
Standard Deviation 0.147
|
-0.116 milligrams per kilogram per day
Standard Deviation 0.152
|
SECONDARY outcome
Timeframe: Baseline up to end of treatment (i.e., anytime up to 64.2 months)Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants who had taken CNI at Baseline and with available data for this outcome measure.
Calcineurin inhibitors included systemic tacrolimus and cyclosporine. Number of participants who took CNI at Baseline and had reduction and discontinuation in CNI use as compared to Baseline during the study are reported in this outcome measure. EOT visit was performed within 3 days after the participant's last dose of study drug. Baseline value was defined as valid and last non-missing value obtained within 28 days prior to participant receiving first study medication.
Outcome measures
| Measure |
Cohort 1: Belumosudil 200 mg QD
n=6 Participants
Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 64.2 months).
|
Cohort 2: Belumosudil 200 mg BID
n=6 Participants
Participants received belumosudil 200 mg orally BID in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 45.9 months).
|
Cohort 3: Belumosudil 400 mg QD
n=11 Participants
Participants received belumosudil 400 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 49.2 months).
|
|---|---|---|---|
|
Number of Participants With Change From Baseline in Calcineurin Inhibitor (CNI) Usage
Participants with reduction in CNI dose
|
5 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With Change From Baseline in Calcineurin Inhibitor (CNI) Usage
Participants who discontinued CNI
|
0 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From the date of first response until documented disease progression or death due to any cause or data cut-off, whichever occurred first (maximum duration: up to 64.2 months)Population: Analysis was performed on responder population which included participants who received at least 1 dose of study medication and achieved a PR or CR response at any post-baseline response assessment.
The DOR was defined as the time (in weeks) from first documentation of response to the time of first documentation of deterioration from best response (e.g., CR to PR, or PR to LR). LOR included the response status of unchanged (LOR-U), mixed (LOR-M), or progression (LOR-P). Per the 2014 NIH Consensus Development Project for Clinical Trials in cGVHD criteria; CR was defined as the resolution of all manifestations in each organ or site; PR was defined as the improvement in at least 1 organ or site without progression in any other organ or site; LOR-M was defined as CR or PR in at least one organ accompanied by progression in another organ, LOR-U was defined as outcomes that did not meet the criteria for CR, PR, progression or mixed response, LOR-P was defined as progression in at least one organ or site without a response in any other organ or site. Kaplan-Meier was used for the analysis.
Outcome measures
| Measure |
Cohort 1: Belumosudil 200 mg QD
n=11 Participants
Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 64.2 months).
|
Cohort 2: Belumosudil 200 mg BID
n=11 Participants
Participants received belumosudil 200 mg orally BID in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 45.9 months).
|
Cohort 3: Belumosudil 400 mg QD
n=12 Participants
Participants received belumosudil 400 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 49.2 months).
|
|---|---|---|---|
|
Duration of Response (DOR)
|
40.0 weeks
Interval 8.14 to
95% CI upper limit was not available because of the less number of participants with event.
|
10.9 weeks
Interval 2.0 to 35.14
|
15.9 weeks
Interval 4.14 to 38.14
|
SECONDARY outcome
Timeframe: From first dose of study drug treatment to the time of first documentation of response or data cut-off, whichever occurred first (maximum duration: up to 64.2 months)Population: Analysis was performed on responder population.
Time-to-response was measured as the time (in weeks) from first dose of study drug to the time of first documentation of response. Response was defined as the participants achieving a PR or CR at any post-baseline response assessment. Per the 2014 NIH Consensus Development Project for Clinical Trials in cGVHD criteria; CR was defined as the resolution of all manifestations in each organ or site and PR was defined as the improvement in at least 1 organ or site without progression in any other organ or site.
Outcome measures
| Measure |
Cohort 1: Belumosudil 200 mg QD
n=11 Participants
Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 64.2 months).
|
Cohort 2: Belumosudil 200 mg BID
n=11 Participants
Participants received belumosudil 200 mg orally BID in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 45.9 months).
|
Cohort 3: Belumosudil 400 mg QD
n=12 Participants
Participants received belumosudil 400 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 49.2 months).
|
|---|---|---|---|
|
Time-to-Response (TTR)
|
8.14 weeks
Interval 7.9 to 26.1
|
8.14 weeks
Interval 4.1 to 40.0
|
8.07 weeks
Interval 4.1 to 67.0
|
SECONDARY outcome
Timeframe: From date of randomization until disease progression or data cut-off, whichever occurred first (maximum duration: up to 64.2 months)Population: Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Here, '0' in the number analyzed field signifies that none of the participants were available for the analysis at the specified time points.
Best response was defined as the percentage of participants with CR or PR. Response was assessed per the 2014 NIH Consensus Development Project for Clinical Trials in cGVHD criteria; CR was defined as the resolution of all manifestations in each organ or site; PR was defined as the improvement in at least 1 organ or site without progression in any other organ or site. Organ response assessment was performed on 9 individual organs: skin, eyes, mouth, esophagus, upper gastrointestinal (GI), lower GI, liver, lungs, and joints and fascia and is reported in this outcome measure.
Outcome measures
| Measure |
Cohort 1: Belumosudil 200 mg QD
n=17 Participants
Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 64.2 months).
|
Cohort 2: Belumosudil 200 mg BID
n=16 Participants
Participants received belumosudil 200 mg orally BID in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 45.9 months).
|
Cohort 3: Belumosudil 400 mg QD
n=21 Participants
Participants received belumosudil 400 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 49.2 months).
|
|---|---|---|---|
|
Percentage of Participants With Best Response in Each Individual Organ
Esophagus
|
50.0 percentage of participants
|
—
|
25.0 percentage of participants
|
|
Percentage of Participants With Best Response in Each Individual Organ
Upper GI tract
|
100.0 percentage of participants
|
100.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Best Response in Each Individual Organ
Skin
|
23.1 percentage of participants
|
16.7 percentage of participants
|
13.3 percentage of participants
|
|
Percentage of Participants With Best Response in Each Individual Organ
Eyes
|
35.7 percentage of participants
|
36.4 percentage of participants
|
23.5 percentage of participants
|
|
Percentage of Participants With Best Response in Each Individual Organ
Mouth
|
46.2 percentage of participants
|
45.5 percentage of participants
|
45.5 percentage of participants
|
|
Percentage of Participants With Best Response in Each Individual Organ
Lower GI tract
|
0 percentage of participants
|
100.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Best Response in Each Individual Organ
Liver
|
—
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants With Best Response in Each Individual Organ
Lungs
|
0 percentage of participants
|
0 percentage of participants
|
30.0 percentage of participants
|
|
Percentage of Participants With Best Response in Each Individual Organ
Joints and Fascia
|
54.5 percentage of participants
|
45.5 percentage of participants
|
41.7 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose of study drug to date of death from any cause or data cut-off, whichever occurred first (maximum duration: up to 64.2 months)Population: Analysis was performed on mITT population.
Overall survival was defined as the time (in months) from first dose of study drug to the death due to any reason. If there was no death, OS was censored by last visit, last long-term follow-up, or study cut-off date, whichever occurred first. Kaplan-Meier survival method was used for the analysis.
Outcome measures
| Measure |
Cohort 1: Belumosudil 200 mg QD
n=17 Participants
Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 64.2 months).
|
Cohort 2: Belumosudil 200 mg BID
n=16 Participants
Participants received belumosudil 200 mg orally BID in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 45.9 months).
|
Cohort 3: Belumosudil 400 mg QD
n=21 Participants
Participants received belumosudil 400 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 49.2 months).
|
|---|---|---|---|
|
Overall Survival (OS)
|
NA months
Interval 39.46 to
Median and the corresponding 95% CI upper limits are not available because majority of the participants were still alive at the time of the final analysis.
|
NA months
Interval 52.07 to
Median and the corresponding 95% CI upper limits are not available because majority of the participants were still alive at the time of the final analysis.
|
NA months
Interval 23.29 to
Median and the corresponding 95% CI upper limits are not available because majority of the participants were still alive at the time of the final analysis.
|
SECONDARY outcome
Timeframe: From time of first treatment to the time of new systemic cGVHD treatment or long term follow-up assessment, whichever occurred first (maximum duration: up to 64.2 months)Population: Analysis was performed on mITT population.
The TTNT was defined as the time (in months) from first treatment to the time of new systemic cGVHD treatment. TTNT was censored by last response assessment or long term follow up assessment, whichever was earlier. Kaplan-Meier survival method was used for the analysis.
Outcome measures
| Measure |
Cohort 1: Belumosudil 200 mg QD
n=17 Participants
Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 64.2 months).
|
Cohort 2: Belumosudil 200 mg BID
n=16 Participants
Participants received belumosudil 200 mg orally BID in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 45.9 months).
|
Cohort 3: Belumosudil 400 mg QD
n=21 Participants
Participants received belumosudil 400 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 49.2 months).
|
|---|---|---|---|
|
Time to Next Therapy (TTNT)
|
15.2 months
Interval 5.22 to
95% CI upper limit was not available due to the less number of participants with events (high percentage of censoring).
|
9.8 months
Interval 4.01 to 19.02
|
14.2 months
Interval 2.66 to
95% CI upper limit was not available due to the less number of participants with events (high percentage of censoring).
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26, 27,28,29,30,31,32,33,34,35,36,37, 38,39,40,41,42,43,44,45,46,47,48, 49, 50,51,52,53, 54,55, 56, 57,58,59,60,61,62,63,67 and EOT (i.e., anytime up to 64.2 months)Population: Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Here, '0' in the number analyzed field signifies that none of the participants were available for the analysis at the specified time points.
Lee cGVHD symptom scale, a patient-reported symptom scale used to measure symptom burden and has 7 subscales (Skin, Eyes and Mouth, Breathing, Eating and Digestion, Muscles and Joints, Energy, and Mental and Emotional) with ratings as follows: 0-Not at all, 1-Slightly, 2-Moderately, 3-Quite a bit, 4-Extremely, with lower values representing better outcome. Score for each subscale was normalized to a score ranged from 0 to 100, where higher score=worse symptoms. An overall Lee cGvHD score was calculated as average of these 7 subscales and it ranged from 0 to 100, where a higher score = worse symptoms. EOT visit was performed within 3 days after the participant's last dose of study drug. Baseline value was defined as valid and last non-missing value obtained within 28 days prior to participant receiving first study medication.
Outcome measures
| Measure |
Cohort 1: Belumosudil 200 mg QD
n=17 Participants
Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 64.2 months).
|
Cohort 2: Belumosudil 200 mg BID
n=16 Participants
Participants received belumosudil 200 mg orally BID in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 45.9 months).
|
Cohort 3: Belumosudil 400 mg QD
n=21 Participants
Participants received belumosudil 400 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 49.2 months).
|
|---|---|---|---|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 2, Day 1
|
—
|
—
|
-5.2 score on a scale
Standard Deviation 6.3
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 3, Day 1
|
-3.0 score on a scale
Standard Deviation 8.5
|
0.5 score on a scale
Standard Deviation 7.3
|
-4.3 score on a scale
Standard Deviation 8.2
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 5, Day 1
|
-3.7 score on a scale
Standard Deviation 11.0
|
-3.7 score on a scale
Standard Deviation 7.0
|
-0.5 score on a scale
Standard Deviation 10.8
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 4, Day 1
|
—
|
—
|
-2.7 score on a scale
Standard Deviation 8.2
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 19, Day 1
|
-7.7 score on a scale
Standard Deviation 19.6
|
-9.9 score on a scale
Standard Deviation 7.8
|
-6.6 score on a scale
Standard Deviation 9.9
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 6, Day 1
|
—
|
—
|
-0.8 score on a scale
Standard Deviation 9.3
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 7, Day 1
|
-4.9 score on a scale
Standard Deviation 8.4
|
-2.2 score on a scale
Standard Deviation 8.8
|
-2.0 score on a scale
Standard Deviation 12.3
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 8, Day 1
|
—
|
-7.1 score on a scale
Standard Deviation 10.1
|
-2.9 score on a scale
Standard Deviation 10.9
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 9, Day 1
|
-3.7 score on a scale
Standard Deviation 10.7
|
-4.2 score on a scale
Standard Deviation 5.5
|
-3.6 score on a scale
Standard Deviation 10.2
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 10, Day 1
|
—
|
-2.7 score on a scale
Standard Deviation 6.1
|
-3.7 score on a scale
Standard Deviation 9.9
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 11, Day 1
|
-3.4 score on a scale
Standard Deviation 11.5
|
-5.5 score on a scale
Standard Deviation 6.0
|
-4.5 score on a scale
Standard Deviation 6.1
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 12, Day 1
|
-3.9 score on a scale
Standard Deviation 8.1
|
-7.6 score on a scale
Standard Deviation 7.7
|
-2.8 score on a scale
Standard Deviation 6.0
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 13, Day 1
|
-5.8 score on a scale
Standard Deviation 14.7
|
-5.9 score on a scale
Standard Deviation 8.8
|
-0.6 score on a scale
Standard Deviation 7.1
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 14, Day 1
|
-1.6 score on a scale
Standard Deviation 17.1
|
-5.0 score on a scale
Standard Deviation 7.3
|
-1.5 score on a scale
Standard Deviation 7.7
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 15, Day 1
|
-4.8 score on a scale
Standard Deviation 15.8
|
-6.8 score on a scale
Standard Deviation 7.0
|
-3.2 score on a scale
Standard Deviation 8.2
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 16, Day 1
|
-4.6 score on a scale
Standard Deviation 16.1
|
-6.9 score on a scale
Standard Deviation 7.6
|
1.9 score on a scale
Standard Deviation 7.9
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 17, Day 1
|
-4.1 score on a scale
Standard Deviation 17.2
|
-10.1 score on a scale
Standard Deviation 5.5
|
0.0 score on a scale
Standard Deviation 12.5
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 18, Day 1
|
-2.3 score on a scale
Standard Deviation 17.6
|
-11.5 score on a scale
Standard Deviation 8.4
|
-2.3 score on a scale
Standard Deviation 7.8
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 20, Day 1
|
-4.6 score on a scale
Standard Deviation 22.0
|
-9.0 score on a scale
Standard Deviation 10.3
|
-2.8 score on a scale
Standard Deviation 5.6
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 21, Day 1
|
-3.1 score on a scale
Standard Deviation 19.1
|
-7.5 score on a scale
Standard Deviation 10.7
|
-4.0 score on a scale
Standard Deviation 7.9
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 22, Day 1
|
-4.1 score on a scale
Standard Deviation 18.9
|
-14.5 score on a scale
Standard Deviation 9.1
|
-3.6 score on a scale
Standard Deviation 5.0
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 23, Day 1
|
-4.1 score on a scale
Standard Deviation 19.1
|
-11.6 score on a scale
Standard Deviation 9.3
|
-6.2 score on a scale
Standard Deviation 7.7
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 24, Day 1
|
-6.7 score on a scale
Standard Deviation 21.0
|
-18.7 score on a scale
|
-5.6 score on a scale
Standard Deviation 5.7
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 25, Day 1
|
2.2 score on a scale
Standard Deviation 18.8
|
-12.4 score on a scale
Standard Deviation 8.2
|
-8.4 score on a scale
Standard Deviation 3.4
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 26, Day 1
|
1.3 score on a scale
Standard Deviation 14.3
|
—
|
0.2 score on a scale
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 27, Day 1
|
-3.5 score on a scale
Standard Deviation 25.3
|
-13.2 score on a scale
Standard Deviation 6.6
|
-6.0 score on a scale
Standard Deviation 9.6
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 28, Day 1
|
4.4 score on a scale
Standard Deviation 13.4
|
—
|
2.6 score on a scale
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 29, Day 1
|
-2.8 score on a scale
Standard Deviation 23.7
|
-11.0 score on a scale
Standard Deviation 7.3
|
-3.7 score on a scale
Standard Deviation 13.0
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 30, Day 1
|
9.0 score on a scale
Standard Deviation 7.5
|
—
|
—
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 31, Day 1
|
-4.8 score on a scale
Standard Deviation 27.9
|
-15.6 score on a scale
Standard Deviation 4.3
|
-12.9 score on a scale
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 32, Day 1
|
10.3 score on a scale
Standard Deviation 6.9
|
—
|
—
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 33, Day 1
|
0.5 score on a scale
Standard Deviation 20.7
|
-13.5 score on a scale
Standard Deviation 9.0
|
-12.9 score on a scale
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 34, Day 1
|
13.5 score on a scale
Standard Deviation 3.6
|
—
|
—
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 35, Day 1
|
-2.5 score on a scale
Standard Deviation 23.3
|
-11.0 score on a scale
Standard Deviation 12.4
|
-12.9 score on a scale
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 36, Day 1
|
7.5 score on a scale
Standard Deviation 6.4
|
—
|
—
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 37, Day 1
|
-5.3 score on a scale
Standard Deviation 29.0
|
-13.6 score on a scale
Standard Deviation 8.1
|
—
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 38, Day 1
|
9.1 score on a scale
Standard Deviation 5.2
|
—
|
—
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 39, Day 1
|
-6.2 score on a scale
Standard Deviation 25.9
|
-14.3 score on a scale
Standard Deviation 8.5
|
-12.9 score on a scale
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 40, Day 1
|
2.7 score on a scale
|
—
|
—
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 41, Day 1
|
-25.7 score on a scale
|
-19.3 score on a scale
|
-12.9 score on a scale
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 42, Day 1
|
4.6 score on a scale
|
—
|
—
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 43, Day 1
|
-20.4 score on a scale
|
-19.9 score on a scale
|
-12.9 score on a scale
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 44, Day 1
|
4.3 score on a scale
|
—
|
—
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 45, Day 1
|
—
|
—
|
-12.3 score on a scale
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 46, Day 1
|
4.6 score on a scale
|
—
|
—
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 47, Day 1
|
-6.8 score on a scale
|
-16.8 score on a scale
|
-12.9 score on a scale
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 48, Day 1
|
2.4 score on a scale
|
—
|
—
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 49, Day 1
|
—
|
-15.4 score on a scale
|
-14.3 score on a scale
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 50, Day 1
|
4.5 score on a scale
|
—
|
—
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 51, Day 1
|
-12.0 score on a scale
|
—
|
-12.9 score on a scale
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 52, Day 1
|
6.0 score on a scale
|
—
|
—
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 53, Day 1
|
-19.2 score on a scale
|
—
|
—
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 54, Day 1
|
4.9 score on a scale
|
—
|
—
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 55, Day 1
|
-16.8 score on a scale
|
—
|
—
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 56, Day 1
|
1.8 score on a scale
|
—
|
—
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 57, Day 1
|
-17.6 score on a scale
|
—
|
—
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 58, Day 1
|
5.4 score on a scale
|
—
|
—
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 59, Day 1
|
-12.7 score on a scale
|
—
|
—
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 60, Day 1
|
4.2 score on a scale
|
—
|
—
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 61, Day 1
|
-19.3 score on a scale
|
—
|
—
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 62, Day 1
|
4.4 score on a scale
|
—
|
—
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 63, Day 1
|
-18.0 score on a scale
|
—
|
—
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
Cycle 67, Day 1
|
-21.9 score on a scale
|
—
|
—
|
|
Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points
EOT
|
-4.3 score on a scale
Standard Deviation 11.7
|
-2.4 score on a scale
Standard Deviation 10.9
|
2.5 score on a scale
Standard Deviation 11.9
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27, 29,30,31,32,33,34,35,36,37,38, 39,40,41,43, 47,48,49,51,52,53, 54, 55,56, 57,58,60,61,62,63,67, EOT (i.e., anytime up to 64.2 months)Population: Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Here, '0' in the number analyzed field signifies that none of the participants were available for the analysis at the specified time points.
FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Baseline value was defined as valid and last non-missing value obtained within 28 days prior to participant receiving first study medication. EOT visit was performed within 3 days after the participant's last dose of study drug.
Outcome measures
| Measure |
Cohort 1: Belumosudil 200 mg QD
n=17 Participants
Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 64.2 months).
|
Cohort 2: Belumosudil 200 mg BID
n=16 Participants
Participants received belumosudil 200 mg orally BID in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 45.9 months).
|
Cohort 3: Belumosudil 400 mg QD
n=21 Participants
Participants received belumosudil 400 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 49.2 months).
|
|---|---|---|---|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 12, Day 1
|
-2.0 percent predicted FEV1
|
-1.0 percent predicted FEV1
|
0.3 percent predicted FEV1
Standard Deviation 3.6
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 2, Day 1
|
—
|
—
|
-4.8 percent predicted FEV1
Standard Deviation 6.7
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 3, Day 1
|
1.1 percent predicted FEV1
Standard Deviation 4.8
|
-1.8 percent predicted FEV1
Standard Deviation 7.1
|
-1.5 percent predicted FEV1
Standard Deviation 6.2
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 4, Day 1
|
—
|
—
|
-0.2 percent predicted FEV1
Standard Deviation 8.4
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 5, Day 1
|
-3.3 percent predicted FEV1
Standard Deviation 8.0
|
-5.0 percent predicted FEV1
Standard Deviation 6.5
|
0.5 percent predicted FEV1
Standard Deviation 5.9
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 6, Day 1
|
—
|
—
|
-0.9 percent predicted FEV1
Standard Deviation 6.4
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 7, Day 1
|
-3.5 percent predicted FEV1
Standard Deviation 4.6
|
-2.6 percent predicted FEV1
Standard Deviation 9.4
|
-0.9 percent predicted FEV1
Standard Deviation 11.8
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 8, Day 1
|
—
|
1.0 percent predicted FEV1
|
-1.1 percent predicted FEV1
Standard Deviation 8.0
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 9, Day 1
|
-1.7 percent predicted FEV1
Standard Deviation 6.8
|
-5.9 percent predicted FEV1
Standard Deviation 11.7
|
-3.0 percent predicted FEV1
Standard Deviation 11.8
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 10, Day 1
|
—
|
-6.0 percent predicted FEV1
Standard Deviation 8.5
|
2.7 percent predicted FEV1
Standard Deviation 3.9
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 11, Day 1
|
-4.3 percent predicted FEV1
Standard Deviation 5.2
|
-4.0 percent predicted FEV1
Standard Deviation 8.5
|
-4.4 percent predicted FEV1
Standard Deviation 15.8
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 13, Day 1
|
-5.9 percent predicted FEV1
Standard Deviation 9.3
|
-2.5 percent predicted FEV1
Standard Deviation 14.7
|
-3.5 percent predicted FEV1
Standard Deviation 13.2
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 14, Day 1
|
2.0 percent predicted FEV1
|
0.0 percent predicted FEV1
|
-5.1 percent predicted FEV1
Standard Deviation 9.1
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 15, Day 1
|
-6.7 percent predicted FEV1
Standard Deviation 11.7
|
-2.3 percent predicted FEV1
Standard Deviation 5.1
|
-6.1 percent predicted FEV1
Standard Deviation 12.6
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 16, Day 1
|
2.0 percent predicted FEV1
|
-8.0 percent predicted FEV1
Standard Deviation 15.6
|
-4.5 percent predicted FEV1
Standard Deviation 7.3
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 17, Day 1
|
-5.3 percent predicted FEV1
Standard Deviation 9.1
|
-6.0 percent predicted FEV1
Standard Deviation 7.2
|
-7.9 percent predicted FEV1
Standard Deviation 15.5
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 18, Day 1
|
—
|
-7.5 percent predicted FEV1
Standard Deviation 10.6
|
4.0 percent predicted FEV1
Standard Deviation 6.0
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 19, Day 1
|
-5.2 percent predicted FEV1
Standard Deviation 9.9
|
-6.3 percent predicted FEV1
Standard Deviation 5.5
|
0.5 percent predicted FEV1
Standard Deviation 8.5
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 20, Day 1
|
—
|
-8.0 percent predicted FEV1
Standard Deviation 7.1
|
4.0 percent predicted FEV1
Standard Deviation 10.4
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 21, Day 1
|
-7.4 percent predicted FEV1
Standard Deviation 10.6
|
0.0 percent predicted FEV1
|
-10.0 percent predicted FEV1
Standard Deviation 19.8
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 22, Day 1
|
—
|
-11.0 percent predicted FEV1
Standard Deviation 1.4
|
-6.0 percent predicted FEV1
Standard Deviation 17.0
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 23, Day 1
|
-4.3 percent predicted FEV1
Standard Deviation 14.6
|
-12.5 percent predicted FEV1
Standard Deviation 4.9
|
-4.8 percent predicted FEV1
Standard Deviation 11.2
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 24, Day 1
|
2.0 percent predicted FEV1
|
-18.0 percent predicted FEV1
|
-19.0 percent predicted FEV1
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 25, Day 1
|
-11.0 percent predicted FEV1
Standard Deviation 15.6
|
-12.5 percent predicted FEV1
Standard Deviation 3.5
|
-5.0 percent predicted FEV1
Standard Deviation 11.4
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 26, Day 1
|
0.0 percent predicted FEV1
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 27, Day 1
|
-6.5 percent predicted FEV1
Standard Deviation 13.4
|
-17.0 percent predicted FEV1
Standard Deviation 9.9
|
-10.0 percent predicted FEV1
Standard Deviation 17.0
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 29, Day 1
|
-0.5 percent predicted FEV1
Standard Deviation 9.2
|
17.0 percent predicted FEV1
Standard Deviation 11.3
|
0.0 percent predicted FEV1
Standard Deviation 1.4
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 30, Day 1
|
3.0 percent predicted FEV1
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 31, Day 1
|
-3.5 percent predicted FEV1
Standard Deviation 12.0
|
-19.5 percent predicted FEV1
Standard Deviation 10.6
|
-4.0 percent predicted FEV1
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 32, Day 1
|
1.0 percent predicted FEV1
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 33, Day 1
|
5.0 percent predicted FEV1
Standard Deviation 5.7
|
-1.0 percent predicted FEV1
Standard Deviation 33.9
|
—
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 34, Day 1
|
2.0 percent predicted FEV1
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 35, Day 1
|
5.0 percent predicted FEV1
Standard Deviation 0.0
|
-2.5 percent predicted FEV1
Standard Deviation 30.4
|
-4.0 percent predicted FEV1
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 36, Day 1
|
3.0 percent predicted FEV1
|
—
|
5.0 percent predicted FEV1
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 37, Day 1
|
-1.0 percent predicted FEV1
|
-22.0 percent predicted FEV1
|
—
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 38, Day 1
|
1.0 percent predicted FEV1
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 39, Day 1
|
10.0 percent predicted FEV1
Standard Deviation 2.8
|
-23.0 percent predicted FEV1
Standard Deviation 11.3
|
-5.0 percent predicted FEV1
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 40, Day 1
|
-1.0 percent predicted FEV1
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 41, Day 1
|
15.0 percent predicted FEV1
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 43, Day 1
|
16.0 percent predicted FEV1
|
-21.0 percent predicted FEV1
|
-7.0 percent predicted FEV1
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 47, Day 1
|
5.0 percent predicted FEV1
|
—
|
-5.0 percent predicted FEV1
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 48, Day 1
|
3.0 percent predicted FEV1
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 49, Day 1
|
8.0 percent predicted FEV1
|
—
|
-2.0 percent predicted FEV1
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 51, Day 1
|
8.0 percent predicted FEV1
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 52, Day 1
|
0.0 percent predicted FEV1
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 53, Day 1
|
9.0 percent predicted FEV1
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 54, Day 1
|
4.0 percent predicted FEV1
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 55, Day 1
|
13.0 percent predicted FEV1
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 56, Day 1
|
4.0 percent predicted FEV1
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 57, Day 1
|
13.0 percent predicted FEV1
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 58, Day 1
|
5.0 percent predicted FEV1
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 60, Day 1
|
4.0 percent predicted FEV1
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 61, Day 1
|
10.0 percent predicted FEV1
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 62, Day 1
|
2.0 percent predicted FEV1
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 63, Day 1
|
13.0 percent predicted FEV1
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
Cycle 67, Day 1
|
14.0 percent predicted FEV1
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Each Specified Time Points
EOT
|
-1.4 percent predicted FEV1
Standard Deviation 9.0
|
-10.1 percent predicted FEV1
Standard Deviation 15.7
|
-7.4 percent predicted FEV1
Standard Deviation 14.9
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 2, 3,4, 5,6,7,8,9,10,11,12,13, 14,15,16,17,18,19,20,21,22,23,24,25,26, 27,29,30,31,32,33,34,35,36,37,38,39,40,41,43,47, 48,49, 51,52,53,54, 55, 56,57,58,60,61, 62, 63,67, EOT (i.e., anytime up to 64.2 months)Population: Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Here, '0' in the number analyzed field signifies that none of the participants were available for the analysis at the specified time points.
FVC was the total amount of air (in liters) exhaled from the lungs during the lung function test measured by spirometer which assessed the change in lung function related to the disease status. Baseline value was defined as valid and last non-missing value obtained within 28 days prior to participant receiving first study medication. EOT visit was performed within 3 days after the participant's last dose of study drug.
Outcome measures
| Measure |
Cohort 1: Belumosudil 200 mg QD
n=17 Participants
Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 64.2 months).
|
Cohort 2: Belumosudil 200 mg BID
n=16 Participants
Participants received belumosudil 200 mg orally BID in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 45.9 months).
|
Cohort 3: Belumosudil 400 mg QD
n=21 Participants
Participants received belumosudil 400 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 49.2 months).
|
|---|---|---|---|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 2, Day 1
|
—
|
—
|
-5.5 percent predicted FVC
Standard Deviation 9.9
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 3, Day 1
|
0.5 percent predicted FVC
Standard Deviation 3.8
|
-2.4 percent predicted FVC
Standard Deviation 6.0
|
-3.0 percent predicted FVC
Standard Deviation 6.7
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 4, Day 1
|
—
|
—
|
-0.2 percent predicted FVC
Standard Deviation 8.6
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 5, Day 1
|
-0.5 percent predicted FVC
Standard Deviation 7.1
|
-4.3 percent predicted FVC
Standard Deviation 5.2
|
1.6 percent predicted FVC
Standard Deviation 6.3
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 6, Day 1
|
—
|
—
|
0.8 percent predicted FVC
Standard Deviation 9.5
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 7, Day 1
|
-2.9 percent predicted FVC
Standard Deviation 5.2
|
-1.3 percent predicted FVC
Standard Deviation 6.4
|
2.3 percent predicted FVC
Standard Deviation 9.7
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 8, Day 1
|
—
|
2.0 percent predicted FVC
|
0.4 percent predicted FVC
Standard Deviation 8.9
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 9, Day 1
|
0.4 percent predicted FVC
Standard Deviation 5.1
|
-2.9 percent predicted FVC
Standard Deviation 5.5
|
-0.8 percent predicted FVC
Standard Deviation 9.5
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 10, Day 1
|
—
|
-5.0 percent predicted FVC
Standard Deviation 8.5
|
4.7 percent predicted FVC
Standard Deviation 4.9
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 11, Day 1
|
-1.1 percent predicted FVC
Standard Deviation 7.3
|
-2.7 percent predicted FVC
Standard Deviation 5.6
|
-4.4 percent predicted FVC
Standard Deviation 12.0
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 12, Day 1
|
2.0 percent predicted FVC
|
1.0 percent predicted FVC
|
0.7 percent predicted FVC
Standard Deviation 5.8
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 13, Day 1
|
-2.4 percent predicted FVC
Standard Deviation 7.9
|
-3.3 percent predicted FVC
Standard Deviation 15.4
|
-4.9 percent predicted FVC
Standard Deviation 9.8
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 14, Day 1
|
11.0 percent predicted FVC
|
2.0 percent predicted FVC
|
-2.7 percent predicted FVC
Standard Deviation 7.1
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 15, Day 1
|
-3.7 percent predicted FVC
Standard Deviation 10.4
|
-3.3 percent predicted FVC
Standard Deviation 5.5
|
-4.8 percent predicted FVC
Standard Deviation 11.5
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 16, Day 1
|
16.0 percent predicted FVC
|
-6.0 percent predicted FVC
Standard Deviation 19.8
|
-6.5 percent predicted FVC
Standard Deviation 6.5
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 17, Day 1
|
-3.2 percent predicted FVC
Standard Deviation 6.3
|
-3.0 percent predicted FVC
Standard Deviation 11.8
|
-5.6 percent predicted FVC
Standard Deviation 12.8
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 18, Day 1
|
—
|
-7.5 percent predicted FVC
Standard Deviation 9.2
|
4.0 percent predicted FVC
Standard Deviation 4.0
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 19, Day 1
|
-2.3 percent predicted FVC
Standard Deviation 6.8
|
-5.3 percent predicted FVC
Standard Deviation 4.7
|
0.8 percent predicted FVC
Standard Deviation 5.1
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 20, Day 1
|
—
|
-10.5 percent predicted FVC
Standard Deviation 2.1
|
-2.0 percent predicted FVC
Standard Deviation 5.6
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 21, Day 1
|
-3.2 percent predicted FVC
Standard Deviation 8.1
|
-3.0 percent predicted FVC
|
-6.6 percent predicted FVC
Standard Deviation 17.0
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 22, Day 1
|
—
|
-11.0 percent predicted FVC
Standard Deviation 0.0
|
-6.0 percent predicted FVC
Standard Deviation 8.5
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 23, Day 1
|
0.0 percent predicted FVC
Standard Deviation 12.3
|
-11.0 percent predicted FVC
Standard Deviation 2.8
|
-1.8 percent predicted FVC
Standard Deviation 10.6
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 24, Day 1
|
4.0 percent predicted FVC
|
-13.0 percent predicted FVC
|
-15.0 percent predicted FVC
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 25, Day 1
|
-7.0 percent predicted FVC
Standard Deviation 11.3
|
-10.5 percent predicted FVC
Standard Deviation 3.5
|
-1.3 percent predicted FVC
Standard Deviation 11.7
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 26, Day 1
|
4.0 percent predicted FVC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 27, Day 1
|
-2.0 percent predicted FVC
Standard Deviation 4.2
|
-18.0 percent predicted FVC
Standard Deviation 12.7
|
-4.0 percent predicted FVC
Standard Deviation 21.2
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 29, Day 1
|
2.5 percent predicted FVC
Standard Deviation 4.9
|
-11.0 percent predicted FVC
|
6.0 percent predicted FVC
Standard Deviation 1.4
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 30, Day 1
|
4.0 percent predicted FVC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 31, Day 1
|
1.5 percent predicted FVC
Standard Deviation 3.5
|
-15.5 percent predicted FVC
Standard Deviation 7.8
|
-4.0 percent predicted FVC
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 32, Day 1
|
2.0 percent predicted FVC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 33, Day 1
|
11.0 percent predicted FVC
Standard Deviation 0.0
|
-17.5 percent predicted FVC
Standard Deviation 7.8
|
—
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 34, Day 1
|
6.0 percent predicted FVC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 35, Day 1
|
11.0 percent predicted FVC
Standard Deviation 5.7
|
-15.0 percent predicted FVC
Standard Deviation 11.3
|
-3.0 percent predicted FVC
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 36, Day 1
|
5.0 percent predicted FVC
|
—
|
2.0 percent predicted FVC
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 37, Day 1
|
7.0 percent predicted FVC
|
-24.0 percent predicted FVC
|
—
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 38, Day 1
|
2.0 percent predicted FVC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 39, Day 1
|
12.5 percent predicted FVC
Standard Deviation 0.7
|
-20.5 percent predicted FVC
Standard Deviation 12.0
|
-1.0 percent predicted FVC
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 40, Day 1
|
3.0 percent predicted FVC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 41, Day 1
|
15.0 percent predicted FVC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 43, Day 1
|
17.0 percent predicted FVC
|
-18.0 percent predicted FVC
|
-4.0 percent predicted FVC
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 47, Day 1
|
5.0 percent predicted FVC
|
—
|
-2.0 percent predicted FVC
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 48, Day 1
|
5.0 percent predicted FVC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 49, Day 1
|
6.0 percent predicted FVC
|
—
|
2.0 percent predicted FVC
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 51, Day 1
|
9.0 percent predicted FVC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 52, Day 1
|
3.0 percent predicted FVC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 53, Day 1
|
8.0 percent predicted FVC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 54, Day 1
|
5.0 percent predicted FVC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 55, Day 1
|
13.0 percent predicted FVC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 56, Day 1
|
7.0 percent predicted FVC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 57, Day 1
|
14.0 percent predicted FVC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 58, Day 1
|
7.0 percent predicted FVC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 60, Day 1
|
8.0 percent predicted FVC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 61, Day 1
|
12.0 percent predicted FVC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 62, Day 1
|
5.0 percent predicted FVC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 63, Day 1
|
12.0 percent predicted FVC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
Cycle 67, Day 1
|
14.0 percent predicted FVC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Each Specified Time Points
EOT
|
-2.5 percent predicted FVC
Standard Deviation 10.3
|
-8.4 percent predicted FVC
Standard Deviation 9.2
|
-7.8 percent predicted FVC
Standard Deviation 14.7
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 2,3,4,5,6,7,8,9,10,11,12,13, 14,15,16,17,18,19,20,21,22,23,24,25,26,27, 29,31,32,33,34,35,36,37,39,40,41,43,47,49,51,53,55, 61, 62, 63, 67, EOT (i.e., anytime up to 64.2 Months)Population: Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Here, '0' in the number analyzed field signifies that none of the participants were available for the analysis at the specified time points.
DLco is a measurement of the ability of the lungs to transfer gases from the air to the blood. Change from baseline in diffusing capacity of the lung for carbon monoxide (percent predicted hemoglobin level corrected) was reported for this measure. Baseline value was defined as valid and last non-missing value obtained within 28 days prior to participant receiving first study medication. EOT visit was performed within 3 days after the participant's last dose of study drug.
Outcome measures
| Measure |
Cohort 1: Belumosudil 200 mg QD
n=17 Participants
Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 64.2 months).
|
Cohort 2: Belumosudil 200 mg BID
n=16 Participants
Participants received belumosudil 200 mg orally BID in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 45.9 months).
|
Cohort 3: Belumosudil 400 mg QD
n=21 Participants
Participants received belumosudil 400 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 49.2 months).
|
|---|---|---|---|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 2, Day 1
|
—
|
—
|
-5.243 Percent Predicted HGB Corrected DLco
Standard Deviation 9.830
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 3, Day 1
|
4.545 Percent Predicted HGB Corrected DLco
Standard Deviation 22.991
|
-0.638 Percent Predicted HGB Corrected DLco
Standard Deviation 7.059
|
-3.928 Percent Predicted HGB Corrected DLco
Standard Deviation 9.492
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 4, Day 1
|
—
|
—
|
0.278 Percent Predicted HGB Corrected DLco
Standard Deviation 9.683
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 5, Day 1
|
4.635 Percent Predicted HGB Corrected DLco
Standard Deviation 23.989
|
-4.462 Percent Predicted HGB Corrected DLco
Standard Deviation 23.621
|
-4.111 Percent Predicted HGB Corrected DLco
Standard Deviation 9.138
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 6, Day 1
|
—
|
—
|
-3.143 Percent Predicted HGB Corrected DLco
Standard Deviation 10.385
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 7, Day 1
|
1.521 Percent Predicted HGB Corrected DLco
Standard Deviation 19.836
|
6.184 Percent Predicted HGB Corrected DLco
Standard Deviation 9.436
|
-4.275 Percent Predicted HGB Corrected DLco
Standard Deviation 11.464
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 8, Day 1
|
—
|
3.554 Percent Predicted HGB Corrected DLco
|
-3.787 Percent Predicted HGB Corrected DLco
Standard Deviation 11.983
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 9, Day 1
|
-4.514 Percent Predicted HGB Corrected DLco
Standard Deviation 7.401
|
2.570 Percent Predicted HGB Corrected DLco
Standard Deviation 8.902
|
-2.540 Percent Predicted HGB Corrected DLco
Standard Deviation 11.897
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 10, Day 1
|
—
|
4.343 Percent Predicted HGB Corrected DLco
Standard Deviation 3.144
|
1.328 Percent Predicted HGB Corrected DLco
Standard Deviation 8.887
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 11, Day 1
|
-0.625 Percent Predicted HGB Corrected DLco
Standard Deviation 7.262
|
6.582 Percent Predicted HGB Corrected DLco
Standard Deviation 10.695
|
-2.720 Percent Predicted HGB Corrected DLco
Standard Deviation 10.920
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 12, Day 1
|
0.531 Percent Predicted HGB Corrected DLco
|
4.076 Percent Predicted HGB Corrected DLco
|
-1.378 Percent Predicted HGB Corrected DLco
Standard Deviation 6.364
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 13, Day 1
|
-5.548 Percent Predicted HGB Corrected DLco
Standard Deviation 12.175
|
1.882 Percent Predicted HGB Corrected DLco
Standard Deviation 7.522
|
2.091 Percent Predicted HGB Corrected DLco
Standard Deviation 13.290
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 14, Day 1
|
12.916 Percent Predicted HGB Corrected DLco
|
0.358 Percent Predicted HGB Corrected DLco
|
0.309 Percent Predicted HGB Corrected DLco
Standard Deviation 11.651
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 15, Day 1
|
0.228 Percent Predicted HGB Corrected DLco
Standard Deviation 15.731
|
1.125 Percent Predicted HGB Corrected DLco
Standard Deviation 5.927
|
-5.309 Percent Predicted HGB Corrected DLco
Standard Deviation 11.514
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 16, Day 1
|
48.465 Percent Predicted HGB Corrected DLco
|
-6.618 Percent Predicted HGB Corrected DLco
Standard Deviation 15.443
|
-6.840 Percent Predicted HGB Corrected DLco
Standard Deviation 15.053
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 17, Day 1
|
-1.018 Percent Predicted HGB Corrected DLco
Standard Deviation 9.226
|
8.458 Percent Predicted HGB Corrected DLco
Standard Deviation 6.229
|
-10.865 Percent Predicted HGB Corrected DLco
Standard Deviation 13.346
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 18, Day 1
|
—
|
15.543 Percent Predicted HGB Corrected DLco
Standard Deviation 11.753
|
-3.174 Percent Predicted HGB Corrected DLco
Standard Deviation 3.106
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 19, Day 1
|
-2.293 Percent Predicted HGB Corrected DLco
Standard Deviation 5.763
|
1.824 Percent Predicted HGB Corrected DLco
Standard Deviation 8.539
|
-2.020 Percent Predicted HGB Corrected DLco
Standard Deviation 2.436
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 20, Day 1
|
—
|
-14.692 Percent Predicted HGB Corrected DLco
|
-13.517 Percent Predicted HGB Corrected DLco
Standard Deviation 5.936
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 21, Day 1
|
-2.778 Percent Predicted HGB Corrected DLco
Standard Deviation 8.187
|
-10.661 Percent Predicted HGB Corrected DLco
|
-12.354 Percent Predicted HGB Corrected DLco
Standard Deviation 12.800
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 22, Day 1
|
—
|
3.347 Percent Predicted HGB Corrected DLco
Standard Deviation 3.560
|
-17.222 Percent Predicted HGB Corrected DLco
Standard Deviation 16.947
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 23, Day 1
|
0.354 Percent Predicted HGB Corrected DLco
Standard Deviation 1.844
|
-15.184 Percent Predicted HGB Corrected DLco
Standard Deviation 20.181
|
-2.219 Percent Predicted HGB Corrected DLco
Standard Deviation 10.614
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 24, Day 1
|
6.945 Percent Predicted HGB Corrected DLco
|
-18.095 Percent Predicted HGB Corrected DLco
|
-11.430 Percent Predicted HGB Corrected DLco
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 25, Day 1
|
-4.461 Percent Predicted HGB Corrected DLco
Standard Deviation 19.865
|
6.289 Percent Predicted HGB Corrected DLco
Standard Deviation 2.469
|
-13.392 Percent Predicted HGB Corrected DLco
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 26, Day 1
|
4.715 Percent Predicted HGB Corrected DLco
|
—
|
—
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 27, Day 1
|
-8.047 Percent Predicted HGB Corrected DLco
Standard Deviation 24.788
|
-9.914 Percent Predicted HGB Corrected DLco
Standard Deviation 15.387
|
-11.154 Percent Predicted HGB Corrected DLco
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 29, Day 1
|
-6.701 Percent Predicted HGB Corrected DLco
Standard Deviation 1.671
|
-18.814 Percent Predicted HGB Corrected DLco
Standard Deviation 24.960
|
8.613 Percent Predicted HGB Corrected DLco
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 31, Day 1
|
2.343 Percent Predicted HGB Corrected DLco
Standard Deviation 20.988
|
-0.800 Percent Predicted HGB Corrected DLco
Standard Deviation 17.528
|
10.833 Percent Predicted HGB Corrected DLco
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 32, Day 1
|
5.586 Percent Predicted HGB Corrected DLco
|
—
|
—
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 33, Day 1
|
9.901 Percent Predicted HGB Corrected DLco
Standard Deviation 9.954
|
-5.962 Percent Predicted HGB Corrected DLco
Standard Deviation 10.550
|
—
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 34, Day 1
|
4.863 Percent Predicted HGB Corrected DLco
|
—
|
—
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 35, Day 1
|
13.867 Percent Predicted HGB Corrected DLco
Standard Deviation 1.309
|
-0.426 Percent Predicted HGB Corrected DLco
Standard Deviation 6.677
|
5.088 Percent Predicted HGB Corrected DLco
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 36, Day 1
|
4.166 Percent Predicted HGB Corrected DLco
|
—
|
10.372 Percent Predicted HGB Corrected DLco
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 37, Day 1
|
9.306 Percent Predicted HGB Corrected DLco
|
-19.228 Percent Predicted HGB Corrected DLco
|
—
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 39, Day 1
|
14.754 Percent Predicted HGB Corrected DLco
Standard Deviation 0.649
|
-6.813 Percent Predicted HGB Corrected DLco
Standard Deviation 12.810
|
5.902 Percent Predicted HGB Corrected DLco
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 40, Day 1
|
5.586 Percent Predicted HGB Corrected DLco
|
—
|
—
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 41, Day 1
|
22.884 Percent Predicted HGB Corrected DLco
|
—
|
—
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 43, Day 1
|
15.213 Percent Predicted HGB Corrected DLco
|
8.775 Percent Predicted HGB Corrected DLco
|
16.351 Percent Predicted HGB Corrected DLco
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 47, Day 1
|
9.660 Percent Predicted HGB Corrected DLco
|
—
|
—
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 49, Day 1
|
-3.599 Percent Predicted HGB Corrected DLco
|
—
|
—
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 51, Day 1
|
11.734 Percent Predicted HGB Corrected DLco
|
—
|
—
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 53, Day 1
|
10.292 Percent Predicted HGB Corrected DLco
|
—
|
—
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 55, Day 1
|
16.550 Percent Predicted HGB Corrected DLco
|
—
|
—
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 61, Day 1
|
17.682 Percent Predicted HGB Corrected DLco
|
—
|
—
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 62, Day 1
|
4.170 Percent Predicted HGB Corrected DLco
|
—
|
—
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 63, Day 1
|
26.215 Percent Predicted HGB Corrected DLco
|
—
|
—
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
Cycle 67, Day 1
|
41.384 Percent Predicted HGB Corrected DLco
|
—
|
—
|
|
Change From Baseline in Percent Predicted Hemoglobin (HGB) Corrected Diffusing Capacity of Lung for Carbon Monoxide (DLco) at Each Specified Time Points
EOT
|
-1.962 Percent Predicted HGB Corrected DLco
Standard Deviation 11.426
|
0.985 Percent Predicted HGB Corrected DLco
Standard Deviation 5.919
|
-10.371 Percent Predicted HGB Corrected DLco
Standard Deviation 14.208
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 2,3, 4, 5,6,7, 8, 9, 10,11,12,13, 14, 15, 16, 17, 18, 19, 20,21, 22,23,24, 25, 26, 27,29, 30, 31,32, 33, 34, 35,36, 37, 38,39, 40,41,43,47, 48, 49,51,52,53, 54,55,56,57,58, 60,61,62, 63, 67, EOT (i.e., anytime up to 64.2 Months)Population: Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Here, '0' in the number analyzed field signifies that none of the participants were available for the analysis at the specified time points.
TLC is the volume of air in the lungs upon the maximum effort of inspiration. Baseline value was defined as valid and last non-missing value obtained within 28 days prior to participant receiving first study medication. EOT visit was performed within 3 days after the participant's last dose of study drug.
Outcome measures
| Measure |
Cohort 1: Belumosudil 200 mg QD
n=17 Participants
Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 64.2 months).
|
Cohort 2: Belumosudil 200 mg BID
n=16 Participants
Participants received belumosudil 200 mg orally BID in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 45.9 months).
|
Cohort 3: Belumosudil 400 mg QD
n=21 Participants
Participants received belumosudil 400 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 49.2 months).
|
|---|---|---|---|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 2, Day 1
|
—
|
—
|
-9.0 Percent Predicted TLC
Standard Deviation 13.4
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 3, Day 1
|
1.6 Percent Predicted TLC
Standard Deviation 11.9
|
1.9 Percent Predicted TLC
Standard Deviation 8.5
|
-0.6 Percent Predicted TLC
Standard Deviation 14.8
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 4, Day 1
|
—
|
—
|
3.3 Percent Predicted TLC
Standard Deviation 14.0
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 5, Day 1
|
-2.6 Percent Predicted TLC
Standard Deviation 16.8
|
-7.2 Percent Predicted TLC
Standard Deviation 10.5
|
-1.7 Percent Predicted TLC
Standard Deviation 11.2
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 6, Day 1
|
—
|
—
|
-4.4 Percent Predicted TLC
Standard Deviation 11.6
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 7, Day 1
|
-3.7 Percent Predicted TLC
Standard Deviation 6.6
|
-4.4 Percent Predicted TLC
Standard Deviation 6.3
|
-2.6 Percent Predicted TLC
Standard Deviation 13.4
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 8, Day 1
|
—
|
-5.0 Percent Predicted TLC
|
-0.2 Percent Predicted TLC
Standard Deviation 12.9
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 9, Day 1
|
-2.9 Percent Predicted TLC
Standard Deviation 6.1
|
-6.0 Percent Predicted TLC
Standard Deviation 8.5
|
-0.9 Percent Predicted TLC
Standard Deviation 15.8
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 10, Day 1
|
—
|
-18.5 Percent Predicted TLC
Standard Deviation 6.4
|
3.6 Percent Predicted TLC
Standard Deviation 14.7
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 11, Day 1
|
0.7 Percent Predicted TLC
Standard Deviation 4.3
|
-5.2 Percent Predicted TLC
Standard Deviation 11.2
|
-3.0 Percent Predicted TLC
Standard Deviation 19.7
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 12, Day 1
|
-9.0 Percent Predicted TLC
|
0.0 Percent Predicted TLC
|
-8.0 Percent Predicted TLC
Standard Deviation 14.2
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 13, Day 1
|
-0.3 Percent Predicted TLC
Standard Deviation 7.1
|
-10.3 Percent Predicted TLC
Standard Deviation 18.7
|
-3.3 Percent Predicted TLC
Standard Deviation 17.6
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 14, Day 1
|
23.0 Percent Predicted TLC
|
-7.0 Percent Predicted TLC
|
-5.8 Percent Predicted TLC
Standard Deviation 16.5
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 15, Day 1
|
-2.8 Percent Predicted TLC
Standard Deviation 10.8
|
-1.0 Percent Predicted TLC
Standard Deviation 5.6
|
-7.0 Percent Predicted TLC
Standard Deviation 12.0
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 16, Day 1
|
-3.0 Percent Predicted TLC
|
-14.0 Percent Predicted TLC
Standard Deviation 12.7
|
-15.5 Percent Predicted TLC
Standard Deviation 9.5
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 17, Day 1
|
-3.0 Percent Predicted TLC
Standard Deviation 6.2
|
-17.0 Percent Predicted TLC
Standard Deviation 11.4
|
-18.1 Percent Predicted TLC
Standard Deviation 15.6
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 18, Day 1
|
—
|
-16.0 Percent Predicted TLC
Standard Deviation 8.5
|
0.0 Percent Predicted TLC
Standard Deviation 13.9
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 19, Day 1
|
-4.6 Percent Predicted TLC
Standard Deviation 6.1
|
-7.7 Percent Predicted TLC
Standard Deviation 10.5
|
-7.0 Percent Predicted TLC
Standard Deviation 5.4
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 20, Day 1
|
—
|
-9.5 Percent Predicted TLC
Standard Deviation 16.3
|
-9.3 Percent Predicted TLC
Standard Deviation 15.4
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 21, Day 1
|
0.3 Percent Predicted TLC
Standard Deviation 9.3
|
-18.0 Percent Predicted TLC
|
-14.4 Percent Predicted TLC
Standard Deviation 24.0
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 22, Day 1
|
—
|
-18.5 Percent Predicted TLC
Standard Deviation 6.4
|
-21.0 Percent Predicted TLC
Standard Deviation 14.1
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 23, Day 1
|
0.0 Percent Predicted TLC
Standard Deviation 8.7
|
-21.0 Percent Predicted TLC
Standard Deviation 19.8
|
-2.8 Percent Predicted TLC
Standard Deviation 18.8
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 24, Day 1
|
0.0 Percent Predicted TLC
|
-15.0 Percent Predicted TLC
|
-34.0 Percent Predicted TLC
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 25, Day 1
|
-3.0 Percent Predicted TLC
Standard Deviation 7.1
|
-19.5 Percent Predicted TLC
Standard Deviation 13.4
|
-6.3 Percent Predicted TLC
Standard Deviation 24.1
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 26, Day 1
|
0.0 Percent Predicted TLC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 27, Day 1
|
5.5 Percent Predicted TLC
Standard Deviation 16.3
|
-24.0 Percent Predicted TLC
Standard Deviation 12.7
|
-14.5 Percent Predicted TLC
Standard Deviation 24.7
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 29, Day 1
|
-1.0 Percent Predicted TLC
Standard Deviation 17.0
|
-27.5 Percent Predicted TLC
Standard Deviation 21.9
|
12.0 Percent Predicted TLC
Standard Deviation 14.1
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 30, Day 1
|
7.0 Percent Predicted TLC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 31, Day 1
|
7.5 Percent Predicted TLC
Standard Deviation 17.7
|
-36.0 Percent Predicted TLC
|
17.0 Percent Predicted TLC
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 32, Day 1
|
1.0 Percent Predicted TLC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 33, Day 1
|
14.0 Percent Predicted TLC
Standard Deviation 11.3
|
-39.0 Percent Predicted TLC
|
—
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 34, Day 1
|
2.0 Percent Predicted TLC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 35, Day 1
|
10.5 Percent Predicted TLC
Standard Deviation 7.8
|
-23.5 Percent Predicted TLC
Standard Deviation 16.3
|
13.0 Percent Predicted TLC
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 36, Day 1
|
6.0 Percent Predicted TLC
|
—
|
-6.0 Percent Predicted TLC
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 37, Day 1
|
-7.0 Percent Predicted TLC
|
-41.0 Percent Predicted TLC
|
—
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 38, Day 1
|
2.0 Percent Predicted TLC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 39, Day 1
|
24.0 Percent Predicted TLC
Standard Deviation 28.3
|
-30.0 Percent Predicted TLC
Standard Deviation 21.2
|
23.0 Percent Predicted TLC
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 40, Day 1
|
0.0 Percent Predicted TLC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 41, Day 1
|
38.0 Percent Predicted TLC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 43, Day 1
|
33.0 Percent Predicted TLC
|
-16.0 Percent Predicted TLC
|
21.0 Percent Predicted TLC
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 47, Day 1
|
19.0 Percent Predicted TLC
|
—
|
25.0 Percent Predicted TLC
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 48, Day 1
|
-13.0 Percent Predicted TLC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 49, Day 1
|
5.0 Percent Predicted TLC
|
—
|
1.0 Percent Predicted TLC
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 51, Day 1
|
15.0 Percent Predicted TLC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 52, Day 1
|
1.0 Percent Predicted TLC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 53, Day 1
|
15.0 Percent Predicted TLC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 54, Day 1
|
4.0 Percent Predicted TLC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 55, Day 1
|
29.0 Percent Predicted TLC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 56, Day 1
|
9.0 Percent Predicted TLC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 57, Day 1
|
18.0 Percent Predicted TLC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 58, Day 1
|
5.0 Percent Predicted TLC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 60, Day 1
|
-3.0 Percent Predicted TLC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 61, Day 1
|
5.0 Percent Predicted TLC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 62, Day 1
|
-1.0 Percent Predicted TLC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 63, Day 1
|
12.0 Percent Predicted TLC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
Cycle 67, Day 1
|
12.0 Percent Predicted TLC
|
—
|
—
|
|
Change From Baseline in Percent Predicted Total Lung Capacity (TLC) at Each Specified Time Points
EOT
|
5.2 Percent Predicted TLC
Standard Deviation 27.5
|
-2.4 Percent Predicted TLC
Standard Deviation 15.0
|
-12.6 Percent Predicted TLC
Standard Deviation 20.1
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 2, 3, 4,5, 6,7, 8, 9, 10, 11,12, 13, 14,15, 16,17, 18, 19,20, 21,22,23, 24, 25, 26,27, 29, 30, 31, 32, 33,34, 35,36, 37,38, 39, 40,41, 43,47, 48, 49,51,52,53, 54, 55,56,57, 58,60,61,62,63,67, EOT (i.e., anytime up to 64.2 Months)Population: Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Here, '0' in the number analyzed field signifies that none of the participants were available for the analysis at the specified time points.
RV is the volume of air remaining in the lungs after maximum forceful expiration. Baseline value was defined as valid and last non-missing value obtained within 28 days prior to participant receiving first study medication. EOT visit was performed within 3 days after the participant's last dose of study drug.
Outcome measures
| Measure |
Cohort 1: Belumosudil 200 mg QD
n=17 Participants
Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 64.2 months).
|
Cohort 2: Belumosudil 200 mg BID
n=16 Participants
Participants received belumosudil 200 mg orally BID in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 45.9 months).
|
Cohort 3: Belumosudil 400 mg QD
n=21 Participants
Participants received belumosudil 400 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 49.2 months).
|
|---|---|---|---|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 2, Day 1
|
—
|
—
|
-18.0 percent predicted RV
Standard Deviation 30.1
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 3, Day 1
|
0.2 percent predicted RV
Standard Deviation 22.2
|
-4.6 percent predicted RV
Standard Deviation 18.8
|
9.0 percent predicted RV
Standard Deviation 34.4
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 4, Day 1
|
—
|
—
|
17.8 percent predicted RV
Standard Deviation 29.0
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 5, Day 1
|
5.2 percent predicted RV
Standard Deviation 24.5
|
-11.5 percent predicted RV
Standard Deviation 26.9
|
-3.7 percent predicted RV
Standard Deviation 29.8
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 6, Day 1
|
—
|
—
|
-10.9 percent predicted RV
Standard Deviation 37.5
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 7, Day 1
|
4.9 percent predicted RV
Standard Deviation 29.1
|
-9.9 percent predicted RV
Standard Deviation 17.1
|
-7.5 percent predicted RV
Standard Deviation 33.0
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 8, Day 1
|
—
|
-28.0 percent predicted RV
|
2.5 percent predicted RV
Standard Deviation 39.7
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 9, Day 1
|
6.4 percent predicted RV
Standard Deviation 27.4
|
-19.9 percent predicted RV
Standard Deviation 24.3
|
0.1 percent predicted RV
Standard Deviation 35.6
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 10, Day 1
|
—
|
-47.5 percent predicted RV
Standard Deviation 0.7
|
1.4 percent predicted RV
Standard Deviation 38.2
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 11, Day 1
|
22.1 percent predicted RV
Standard Deviation 29.6
|
-10.5 percent predicted RV
Standard Deviation 28.3
|
5.4 percent predicted RV
Standard Deviation 38.0
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 12, Day 1
|
-28.0 percent predicted RV
|
-5.0 percent predicted RV
|
-22.2 percent predicted RV
Standard Deviation 49.9
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 13, Day 1
|
20.3 percent predicted RV
Standard Deviation 19.9
|
-27.0 percent predicted RV
Standard Deviation 35.6
|
0.3 percent predicted RV
Standard Deviation 32.6
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 14, Day 1
|
78.0 percent predicted RV
|
-31.0 percent predicted RV
|
-6.5 percent predicted RV
Standard Deviation 36.3
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 15, Day 1
|
20.3 percent predicted RV
Standard Deviation 27.4
|
-0.7 percent predicted RV
Standard Deviation 18.1
|
-16.7 percent predicted RV
Standard Deviation 22.3
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 16, Day 1
|
0.0 percent predicted RV
|
-36.5 percent predicted RV
Standard Deviation 13.4
|
-27.5 percent predicted RV
Standard Deviation 31.9
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 17, Day 1
|
13.6 percent predicted RV
Standard Deviation 27.8
|
-47.3 percent predicted RV
Standard Deviation 25.1
|
-39.1 percent predicted RV
Standard Deviation 26.2
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 18, Day 1
|
—
|
-42.0 percent predicted RV
Standard Deviation 0.0
|
-7.3 percent predicted RV
Standard Deviation 33.7
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 19, Day 1
|
5.4 percent predicted RV
Standard Deviation 28.7
|
-19.7 percent predicted RV
Standard Deviation 18.0
|
-23.5 percent predicted RV
Standard Deviation 18.7
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 20, Day 1
|
—
|
-7.5 percent predicted RV
Standard Deviation 37.5
|
-22.0 percent predicted RV
Standard Deviation 44.3
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 21, Day 1
|
8.3 percent predicted RV
Standard Deviation 10.0
|
-44.0 percent predicted RV
|
-30.2 percent predicted RV
Standard Deviation 51.2
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 22, Day 1
|
—
|
-33.0 percent predicted RV
Standard Deviation 19.8
|
-41.0 percent predicted RV
Standard Deviation 46.7
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 23, Day 1
|
0.3 percent predicted RV
Standard Deviation 5.1
|
-72.0 percent predicted RV
|
1.5 percent predicted RV
Standard Deviation 44.8
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 24, Day 1
|
-4.0 percent predicted RV
|
-17.0 percent predicted RV
|
-78.0 percent predicted RV
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 25, Day 1
|
1.0 percent predicted RV
Standard Deviation 9.9
|
-34.0 percent predicted RV
Standard Deviation 31.1
|
-23.3 percent predicted RV
Standard Deviation 56.0
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 26, Day 1
|
-3.0 percent predicted RV
|
—
|
—
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 27, Day 1
|
19.5 percent predicted RV
Standard Deviation 41.7
|
-39.5 percent predicted RV
Standard Deviation 20.5
|
-41.0 percent predicted RV
Standard Deviation 28.3
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 29, Day 1
|
-13.0 percent predicted RV
Standard Deviation 42.4
|
-13.0 percent predicted RV
|
17.5 percent predicted RV
Standard Deviation 40.3
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 30, Day 1
|
21.0 percent predicted RV
|
—
|
—
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 31, Day 1
|
15.0 percent predicted RV
Standard Deviation 43.8
|
-93.0 percent predicted RV
|
61.0 percent predicted RV
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 32, Day 1
|
5.0 percent predicted RV
|
—
|
—
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 33, Day 1
|
14.5 percent predicted RV
Standard Deviation 36.1
|
-70.0 percent predicted RV
|
—
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 34, Day 1
|
-1.0 percent predicted RV
|
—
|
—
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 35, Day 1
|
3.5 percent predicted RV
Standard Deviation 36.1
|
-34.5 percent predicted RV
Standard Deviation 33.2
|
47.0 percent predicted RV
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 36, Day 1
|
17.0 percent predicted RV
|
—
|
-20.0 percent predicted RV
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 37, Day 1
|
-54.0 percent predicted RV
|
-70.0 percent predicted RV
|
—
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 38, Day 1
|
8.0 percent predicted RV
|
—
|
—
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 39, Day 1
|
43.0 percent predicted RV
Standard Deviation 89.1
|
-43.0 percent predicted RV
Standard Deviation 42.4
|
81.0 percent predicted RV
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 40, Day 1
|
-1.0 percent predicted RV
|
—
|
—
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 41, Day 1
|
80.0 percent predicted RV
|
—
|
—
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 43, Day 1
|
58.0 percent predicted RV
|
-26.0 percent predicted RV
|
75.0 percent predicted RV
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 47, Day 1
|
42.0 percent predicted RV
|
—
|
87.0 percent predicted RV
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 48, Day 1
|
-50.0 percent predicted RV
|
—
|
—
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 49, Day 1
|
-14.0 percent predicted RV
|
—
|
-5.0 percent predicted RV
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 51, Day 1
|
22.0 percent predicted RV
|
—
|
—
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 52, Day 1
|
-4.0 percent predicted RV
|
—
|
—
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 53, Day 1
|
22.0 percent predicted RV
|
—
|
—
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 54, Day 1
|
4.0 percent predicted RV
|
—
|
—
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 55, Day 1
|
53.0 percent predicted RV
|
—
|
—
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 56, Day 1
|
17.0 percent predicted RV
|
—
|
—
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 57, Day 1
|
18.0 percent predicted RV
|
—
|
—
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 58, Day 1
|
4.0 percent predicted RV
|
—
|
—
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 60, Day 1
|
-20.0 percent predicted RV
|
—
|
—
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 61, Day 1
|
-18.0 percent predicted RV
|
—
|
—
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 62, Day 1
|
-8.0 percent predicted RV
|
—
|
—
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 63, Day 1
|
6.0 percent predicted RV
|
—
|
—
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
Cycle 67, Day 1
|
2.0 percent predicted RV
|
—
|
—
|
|
Change From Baseline in Percent Predicted Residual Volume (RV) at Each Specified Time Points
EOT
|
6.3 percent predicted RV
Standard Deviation 24.3
|
10.6 percent predicted RV
Standard Deviation 34.9
|
-18.5 percent predicted RV
Standard Deviation 32.6
|
SECONDARY outcome
Timeframe: Cycles 1 and 2: pre-dose (0 hour), 1, 2, 3, 4, 5, and 6 hours post-dose on Day 1Population: Analysis was performed on PK population which included all participants who received at least one dose of study drug and had at least 1 post-dose PK sample drawn. Here, 'number analyzed' = participants with available data for each specified category.
Cmax was the maximum observed plasma concentration, obtained by a non-compartmental analysis. Cmax data for Belumosudil and its metabolites KD025m1 and KD025m2 are reported in this outcome measure.
Outcome measures
| Measure |
Cohort 1: Belumosudil 200 mg QD
n=17 Participants
Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 64.2 months).
|
Cohort 2: Belumosudil 200 mg BID
n=16 Participants
Participants received belumosudil 200 mg orally BID in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 45.9 months).
|
Cohort 3: Belumosudil 400 mg QD
n=21 Participants
Participants received belumosudil 400 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 49.2 months).
|
|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of Belumosudil and Its Metabolites (KD025m1 and KD025m2)
Belumosudil: Cycle 1 Day 1
|
2500 nanograms per milliliter
Geometric Coefficient of Variation 60.1
|
1400 nanograms per milliliter
Geometric Coefficient of Variation 98.5
|
2960 nanograms per milliliter
Geometric Coefficient of Variation 69.7
|
|
Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of Belumosudil and Its Metabolites (KD025m1 and KD025m2)
Belumosudil: Cycle 2 Day 1
|
2020 nanograms per milliliter
Geometric Coefficient of Variation 101
|
1890 nanograms per milliliter
Geometric Coefficient of Variation 120
|
3270 nanograms per milliliter
Geometric Coefficient of Variation 63.0
|
|
Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of Belumosudil and Its Metabolites (KD025m1 and KD025m2)
KD025m1: Cycle 1 Day 1
|
44.4 nanograms per milliliter
Geometric Coefficient of Variation 67.9
|
34.8 nanograms per milliliter
Geometric Coefficient of Variation 58.8
|
63.9 nanograms per milliliter
Geometric Coefficient of Variation 59.4
|
|
Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of Belumosudil and Its Metabolites (KD025m1 and KD025m2)
KD025m1: Cycle 2 Day 1
|
36.2 nanograms per milliliter
Geometric Coefficient of Variation 43.0
|
45.0 nanograms per milliliter
Geometric Coefficient of Variation 38.6
|
55.8 nanograms per milliliter
Geometric Coefficient of Variation 82.1
|
|
Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of Belumosudil and Its Metabolites (KD025m1 and KD025m2)
KD025m2: Cycle 1 Day 1
|
208 nanograms per milliliter
Geometric Coefficient of Variation 93.1
|
99.2 nanograms per milliliter
Geometric Coefficient of Variation 112
|
388 nanograms per milliliter
Geometric Coefficient of Variation 82.3
|
|
Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of Belumosudil and Its Metabolites (KD025m1 and KD025m2)
KD025m2: Cycle 2 Day 1
|
158 nanograms per milliliter
Geometric Coefficient of Variation 150
|
145 nanograms per milliliter
Geometric Coefficient of Variation 147
|
265 nanograms per milliliter
Geometric Coefficient of Variation 154
|
SECONDARY outcome
Timeframe: Cycles 1 and 2: pre-dose (0 hour), 1, 2, 3, 4, 5, and 6 hours post-dose on Day 1Population: Analysis was performed on PK population. Here, 'number analyzed' = participants with available data for each specified category.
Tmax was defined as time to reach maximum observed plasma concentration, obtained by a non-compartmental analysis. Tmax data for Belumosudil and its metabolites KD025m1 and KD025m2 are reported in this outcome measure.
Outcome measures
| Measure |
Cohort 1: Belumosudil 200 mg QD
n=17 Participants
Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 64.2 months).
|
Cohort 2: Belumosudil 200 mg BID
n=16 Participants
Participants received belumosudil 200 mg orally BID in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 45.9 months).
|
Cohort 3: Belumosudil 400 mg QD
n=21 Participants
Participants received belumosudil 400 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 49.2 months).
|
|---|---|---|---|
|
Pharmacokinetics: Time of the Maximum Observed Plasma Concentration (Tmax) of Belumosudil and Its Metabolites (KD025m1 and KD025m2)
Belumosudil: Cycle 1 Day 1
|
2.12 hours
Interval 0.98 to 5.0
|
3.43 hours
Interval 1.97 to 6.0
|
3.03 hours
Interval 1.85 to 6.0
|
|
Pharmacokinetics: Time of the Maximum Observed Plasma Concentration (Tmax) of Belumosudil and Its Metabolites (KD025m1 and KD025m2)
Belumosudil: Cycle 2 Day 1
|
2.53 hours
Interval 0.0 to 4.87
|
2.47 hours
Interval 0.0 to 5.83
|
2.66 hours
Interval 1.0 to 6.02
|
|
Pharmacokinetics: Time of the Maximum Observed Plasma Concentration (Tmax) of Belumosudil and Its Metabolites (KD025m1 and KD025m2)
KD025m1: Cycle 1 Day 1
|
2.50 hours
Interval 1.0 to 3.98
|
1.75 hours
Interval 1.08 to 5.95
|
1.98 hours
Interval 0.9 to 4.95
|
|
Pharmacokinetics: Time of the Maximum Observed Plasma Concentration (Tmax) of Belumosudil and Its Metabolites (KD025m1 and KD025m2)
KD025m1: Cycle 2 Day 1
|
2.98 hours
Interval 1.17 to 3.03
|
2.05 hours
Interval 1.08 to 5.83
|
2.17 hours
Interval 1.0 to 4.03
|
|
Pharmacokinetics: Time of the Maximum Observed Plasma Concentration (Tmax) of Belumosudil and Its Metabolites (KD025m1 and KD025m2)
KD025m2: Cycle 1 Day 1
|
2.82 hours
Interval 1.93 to 5.0
|
3.00 hours
Interval 2.0 to 6.0
|
2.98 hours
Interval 1.85 to 6.0
|
|
Pharmacokinetics: Time of the Maximum Observed Plasma Concentration (Tmax) of Belumosudil and Its Metabolites (KD025m1 and KD025m2)
KD025m2: Cycle 2 Day 1
|
2.98 hours
Interval 0.0 to 3.93
|
2.00 hours
Interval 1.05 to 5.07
|
3.03 hours
Interval 1.98 to 6.02
|
SECONDARY outcome
Timeframe: Cycles 1 and 2: pre-dose (0 hour), 1, 2, 3, 4, 5, and 6 hours post-dose on Day 1Population: Analysis was performed on PK population. Here, 'number analyzed' = participants with available data for each specified category.
AUC0-6hr was defined as area under the plasma concentration versus time curve from time 0 to 6 hours post-dose, obtained by a non-compartmental analysis from the concentration-time data. AUC0-6hr data for Belumosudil and its metabolites KD025m1 and KD025m2 are reported in this outcome measure.
Outcome measures
| Measure |
Cohort 1: Belumosudil 200 mg QD
n=17 Participants
Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 64.2 months).
|
Cohort 2: Belumosudil 200 mg BID
n=16 Participants
Participants received belumosudil 200 mg orally BID in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 45.9 months).
|
Cohort 3: Belumosudil 400 mg QD
n=21 Participants
Participants received belumosudil 400 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 49.2 months).
|
|---|---|---|---|
|
Pharmacokinetics: The Area Under the Plasma Concentration Versus Time Curve From Time 0 to 6 Hours Post-dose (AUC0-6hr) of Belumosudil and Its Metabolites (KD025m1 and KD025m2)
Belumosudil: Cycle 1 Day 1
|
8350 hours*nanograms per milliliter
Geometric Coefficient of Variation 60.3
|
4960 hours*nanograms per milliliter
Geometric Coefficient of Variation 108
|
11500 hours*nanograms per milliliter
Geometric Coefficient of Variation 97.3
|
|
Pharmacokinetics: The Area Under the Plasma Concentration Versus Time Curve From Time 0 to 6 Hours Post-dose (AUC0-6hr) of Belumosudil and Its Metabolites (KD025m1 and KD025m2)
Belumosudil: Cycle 2 Day 1
|
7090 hours*nanograms per milliliter
Geometric Coefficient of Variation 95.9
|
7190 hours*nanograms per milliliter
Geometric Coefficient of Variation 115
|
12000 hours*nanograms per milliliter
Geometric Coefficient of Variation 68.8
|
|
Pharmacokinetics: The Area Under the Plasma Concentration Versus Time Curve From Time 0 to 6 Hours Post-dose (AUC0-6hr) of Belumosudil and Its Metabolites (KD025m1 and KD025m2)
KD025m1: Cycle 1 Day 1
|
140 hours*nanograms per milliliter
Geometric Coefficient of Variation 72.3
|
114 hours*nanograms per milliliter
Geometric Coefficient of Variation 60.8
|
216 hours*nanograms per milliliter
Geometric Coefficient of Variation 61.9
|
|
Pharmacokinetics: The Area Under the Plasma Concentration Versus Time Curve From Time 0 to 6 Hours Post-dose (AUC0-6hr) of Belumosudil and Its Metabolites (KD025m1 and KD025m2)
KD025m1: Cycle 2 Day 1
|
123 hours*nanograms per milliliter
Geometric Coefficient of Variation 38.2
|
160 hours*nanograms per milliliter
Geometric Coefficient of Variation 31.3
|
178 hours*nanograms per milliliter
Geometric Coefficient of Variation 72.9
|
|
Pharmacokinetics: The Area Under the Plasma Concentration Versus Time Curve From Time 0 to 6 Hours Post-dose (AUC0-6hr) of Belumosudil and Its Metabolites (KD025m1 and KD025m2)
KD025m2: Cycle 1 Day 1
|
565 hours*nanograms per milliliter
Geometric Coefficient of Variation 90.8
|
282 hours*nanograms per milliliter
Geometric Coefficient of Variation 125
|
1150 hours*nanograms per milliliter
Geometric Coefficient of Variation 97.1
|
|
Pharmacokinetics: The Area Under the Plasma Concentration Versus Time Curve From Time 0 to 6 Hours Post-dose (AUC0-6hr) of Belumosudil and Its Metabolites (KD025m1 and KD025m2)
KD025m2: Cycle 2 Day 1
|
471 hours*nanograms per milliliter
Geometric Coefficient of Variation 145
|
513 hours*nanograms per milliliter
Geometric Coefficient of Variation 122
|
923 hours*nanograms per milliliter
Geometric Coefficient of Variation 144
|
Adverse Events
Cohort 1 200 mg QD
Serious events: 5 serious events
Other events: 17 other events
Deaths: 5 deaths
Cohort 2 200 mg BID
Serious events: 6 serious events
Other events: 16 other events
Deaths: 5 deaths
Cohort 3 400 mg QD
Serious events: 13 serious events
Other events: 19 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Cohort 1 200 mg QD
n=17 participants at risk
Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 64.2 months).
|
Cohort 2 200 mg BID
n=16 participants at risk
Participants received belumosudil 200 mg orally BID in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 45.9 months).
|
Cohort 3 400 mg QD
n=21 participants at risk
Participants received belumosudil 400 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 49.2 months).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
General disorders
Influenza like illness
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
9.5%
2/21 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Immune system disorders
Anaphylactic reaction
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Immune system disorders
Chronic graft versus host disease in skin
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Immune system disorders
Graft versus host disease in lung
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Infections and infestations
Citrobacter infection
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Infections and infestations
Pneumonia
|
5.9%
1/17 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
14.3%
3/21 • Number of events 3 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Infections and infestations
Stenotrophomonas infection
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Infections and infestations
Varicella zoster virus infection
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Investigations
Influenza A virus test positive
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Investigations
Respirovirus test positive
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Metabolism and nutrition disorders
Lipomatosis
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia recurrent
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia recurrent
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Renal and urinary disorders
Proteinuria
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
14.3%
3/21 • Number of events 3 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
9.5%
2/21 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Respiratory, thoracic and mediastinal disorders
Obliterative bronchiolitis
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Social circumstances
Pregnancy of partner
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Vascular disorders
Embolism
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
Other adverse events
| Measure |
Cohort 1 200 mg QD
n=17 participants at risk
Participants received belumosudil 200 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 64.2 months).
|
Cohort 2 200 mg BID
n=16 participants at risk
Participants received belumosudil 200 mg orally BID in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 45.9 months).
|
Cohort 3 400 mg QD
n=21 participants at risk
Participants received belumosudil 400 mg orally QD in each 28-day treatment cycle until disease progression, unacceptable toxicity, or death whichever occurred first (maximum duration: 49.2 months).
|
|---|---|---|---|
|
Psychiatric disorders
Insomnia
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
14.3%
3/21 • Number of events 3 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Psychiatric disorders
Irritability
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.9%
1/17 • Number of events 4 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
12.5%
2/16 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
9.5%
2/21 • Number of events 6 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Renal and urinary disorders
Chronic kidney disease
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Renal and urinary disorders
Haematuria
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Renal and urinary disorders
Nocturia
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Renal and urinary disorders
Pollakiuria
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Blood and lymphatic system disorders
Anaemia
|
29.4%
5/17 • Number of events 14 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
25.0%
4/16 • Number of events 8 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Cardiac disorders
Palpitations
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Cardiac disorders
Pericardial effusion
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
9.5%
2/21 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Ear and labyrinth disorders
Vertigo
|
11.8%
2/17 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Endocrine disorders
Adrenal insufficiency
|
5.9%
1/17 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Endocrine disorders
Hypogonadism
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Endocrine disorders
Hypothyroidism
|
5.9%
1/17 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
14.3%
3/21 • Number of events 4 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Eye disorders
Blepharitis
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Eye disorders
Dry eye
|
11.8%
2/17 • Number of events 3 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
25.0%
4/16 • Number of events 4 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
9.5%
2/21 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Eye disorders
Eye irritation
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Eye disorders
Eye pain
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
12.5%
2/16 • Number of events 4 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Eye disorders
Eyelid margin crusting
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Eye disorders
Glaucoma
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Eye disorders
Macular degeneration
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Eye disorders
Photophobia
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
9.5%
2/21 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Eye disorders
Vision blurred
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
12.5%
2/16 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
19.0%
4/21 • Number of events 4 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.8%
2/17 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
12.5%
2/16 • Number of events 4 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
19.0%
4/21 • Number of events 6 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Gastrointestinal disorders
Anal incontinence
|
5.9%
1/17 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Gastrointestinal disorders
Constipation
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
14.3%
3/21 • Number of events 4 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Gastrointestinal disorders
Diarrhoea
|
35.3%
6/17 • Number of events 9 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
31.2%
5/16 • Number of events 10 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
33.3%
7/21 • Number of events 11 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
12.5%
2/16 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Gastrointestinal disorders
Dysphagia
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
18.8%
3/16 • Number of events 4 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
9.5%
2/21 • Number of events 3 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Gastrointestinal disorders
Enamel anomaly
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
11.8%
2/17 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
9.5%
2/21 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Gastrointestinal disorders
Nausea
|
35.3%
6/17 • Number of events 10 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
25.0%
4/16 • Number of events 6 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
42.9%
9/21 • Number of events 12 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Gastrointestinal disorders
Stomatitis
|
5.9%
1/17 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
2/17 • Number of events 4 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
18.8%
3/16 • Number of events 3 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
19.0%
4/21 • Number of events 4 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
General disorders
Asthenia
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
General disorders
Catheter site haemorrhage
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
General disorders
Chills
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
General disorders
Fatigue
|
35.3%
6/17 • Number of events 7 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
18.8%
3/16 • Number of events 7 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
47.6%
10/21 • Number of events 14 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
General disorders
Generalised oedema
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
General disorders
Hypothermia
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
General disorders
Impaired healing
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
General disorders
Influenza like illness
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
18.8%
3/16 • Number of events 3 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
General disorders
Oedema
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
General disorders
Oedema peripheral
|
17.6%
3/17 • Number of events 3 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
25.0%
4/16 • Number of events 5 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
28.6%
6/21 • Number of events 6 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
General disorders
Pain
|
17.6%
3/17 • Number of events 3 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
General disorders
Pyrexia
|
5.9%
1/17 • Number of events 3 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
18.8%
3/16 • Number of events 6 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
14.3%
3/21 • Number of events 3 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
12.5%
2/16 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Immune system disorders
Graft versus host disease in gastrointestinal tract
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Infections and infestations
Bronchitis
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
14.3%
3/21 • Number of events 3 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Infections and infestations
Corneal infection
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Infections and infestations
Epstein-Barr virus infection
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Infections and infestations
Fungal infection
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Infections and infestations
Hordeolum
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Infections and infestations
Influenza
|
11.8%
2/17 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
9.5%
2/21 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Infections and infestations
Oral candidiasis
|
11.8%
2/17 • Number of events 3 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Infections and infestations
Pneumonia
|
5.9%
1/17 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
18.8%
3/16 • Number of events 3 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Infections and infestations
Pseudomonas infection
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
9.5%
2/21 • Number of events 3 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Infections and infestations
Respiratory tract infection
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Infections and infestations
Respiratory tract infection fungal
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Infections and infestations
Sinusitis
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
12.5%
2/16 • Number of events 4 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Infections and infestations
Upper respiratory tract infection
|
52.9%
9/17 • Number of events 16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
56.2%
9/16 • Number of events 13 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
33.3%
7/21 • Number of events 9 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
12.5%
2/16 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Injury, poisoning and procedural complications
Contusion
|
11.8%
2/17 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
12.5%
2/16 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
14.3%
3/21 • Number of events 4 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Injury, poisoning and procedural complications
Fall
|
11.8%
2/17 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Injury, poisoning and procedural complications
Limb injury
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Injury, poisoning and procedural complications
Overdose
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
9.5%
2/21 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Investigations
Alanine aminotransferase increased
|
35.3%
6/17 • Number of events 12 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
18.8%
3/16 • Number of events 4 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
9.5%
2/21 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Investigations
Aspartate aminotransferase increased
|
29.4%
5/17 • Number of events 8 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
12.5%
2/16 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Investigations
Blood alkaline phosphatase increased
|
23.5%
4/17 • Number of events 6 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Investigations
Blood chloride decreased
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Investigations
Blood cholesterol increased
|
5.9%
1/17 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Investigations
Blood creatine increased
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Investigations
Blood creatine phosphokinase increased
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Investigations
Blood creatinine increased
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
9.5%
2/21 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Investigations
Bronchoscopy
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Investigations
Gamma-glutamyltransferase increased
|
23.5%
4/17 • Number of events 9 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
25.0%
4/16 • Number of events 4 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Investigations
Glucose urine present
|
11.8%
2/17 • Number of events 3 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 3 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Investigations
Neutrophil count decreased
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Investigations
Platelet count decreased
|
5.9%
1/17 • Number of events 3 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Investigations
Red blood cells urine positive
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Investigations
Urine output decreased
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Investigations
Weight decreased
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
9.5%
2/21 • Number of events 4 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Investigations
Weight increased
|
17.6%
3/17 • Number of events 9 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 4 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Investigations
White blood cell count decreased
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.8%
2/17 • Number of events 4 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
12.5%
2/16 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
19.0%
4/21 • Number of events 4 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Metabolism and nutrition disorders
Dehydration
|
11.8%
2/17 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
18.8%
3/16 • Number of events 4 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
9.5%
2/21 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.8%
2/17 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
14.3%
3/21 • Number of events 8 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
17.6%
3/17 • Number of events 7 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
12.5%
2/16 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
14.3%
3/21 • Number of events 4 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.9%
1/17 • Number of events 6 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
14.3%
3/21 • Number of events 5 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 4 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
12.5%
2/16 • Number of events 3 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
9.5%
2/21 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Metabolism and nutrition disorders
Obesity
|
11.8%
2/17 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
23.8%
5/21 • Number of events 6 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
12.5%
2/16 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
28.6%
6/21 • Number of events 6 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
23.5%
4/17 • Number of events 6 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
9.5%
2/21 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
1/17 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
14.3%
3/21 • Number of events 3 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.8%
2/17 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
12.5%
2/16 • Number of events 3 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
19.0%
4/21 • Number of events 5 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Musculoskeletal and connective tissue disorders
Thoracic spinal stenosis
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease recurrent
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia recurrent
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
12.5%
2/16 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 4 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
9.5%
2/21 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Nervous system disorders
Epidural lipomatosis
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Nervous system disorders
Headache
|
23.5%
4/17 • Number of events 4 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
18.8%
3/16 • Number of events 3 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
28.6%
6/21 • Number of events 8 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Nervous system disorders
Hypoaesthesia
|
5.9%
1/17 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Nervous system disorders
Migraine
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Nervous system disorders
Muscle spasticity
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
18.8%
3/16 • Number of events 3 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Nervous system disorders
Tremor
|
11.8%
2/17 • Number of events 3 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
14.3%
3/21 • Number of events 4 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Psychiatric disorders
Anxiety
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
12.5%
2/16 • Number of events 3 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
14.3%
3/21 • Number of events 3 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Psychiatric disorders
Depression
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
25.0%
4/16 • Number of events 4 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
14.3%
3/21 • Number of events 3 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Renal and urinary disorders
Proteinuria
|
11.8%
2/17 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
11.8%
2/17 • Number of events 4 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Reproductive system and breast disorders
Testicular pain
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Reproductive system and breast disorders
Testicular swelling
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
25.0%
4/16 • Number of events 5 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
33.3%
7/21 • Number of events 9 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.8%
2/17 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
31.2%
5/16 • Number of events 7 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
28.6%
6/21 • Number of events 6 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
12.5%
2/16 • Number of events 5 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
14.3%
3/21 • Number of events 3 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
17.6%
3/17 • Number of events 3 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
11.8%
2/17 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
12.5%
2/16 • Number of events 7 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
11.8%
2/17 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
12.5%
2/16 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
12.5%
2/16 • Number of events 3 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
12.5%
2/16 • Number of events 4 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
1/17 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
11.8%
2/17 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Vascular disorders
Embolism
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
4.8%
1/21 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Vascular disorders
Flushing
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Vascular disorders
Hot flush
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Vascular disorders
Hypertension
|
29.4%
5/17 • Number of events 8 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
12.5%
2/16 • Number of events 5 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
19.0%
4/21 • Number of events 6 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Vascular disorders
Peripheral coldness
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/16 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/17 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
6.2%
1/16 • Number of events 2 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
0.00%
0/21 • From first dose of study drug up to 28 days after the last dose of study drug (maximum duration: up to 64.2 months)
Analysis was performed on the safety population. Disease progression related death was not reported as AE.
|
Additional Information
Trial Transparency Team
Sanofi ( Kadmon, a Sanofi Company )
Phone: 800-633-1610
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
- Publication restrictions are in place
Restriction type: OTHER