Trial Outcomes & Findings for A Study of Duvelisib in Participants With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) (NCT NCT03372057)
NCT ID: NCT03372057
Last Updated: 2025-03-07
Results Overview
ORR was defined as the percentage of participants with CR + PR, as assessed by the investigator using the Lugano criteria, for participants receiving the optimal dose of duvelisib for at least one cycle of study therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
156 participants
Primary outcome timeframe
56 days (2 cycles; 28-day cycles)
Results posted on
2025-03-07
Participant Flow
Regardless of study phase, all participants underwent screening assessments up to 30 days before the first study drug dose.
Participant milestones
| Measure |
Dose Optimization Phase: Cohort 1
Duvelisib was administered orally (PO) twice daily (BID) at a starting dose of 25 milligrams (mg), with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
|
Dose Optimization Phase: Cohort 2
Duvelisib 75 mg PO BID was administered in 28-day cycles.
|
Expansion Phase
Duvelisib PO BID at a starting dose of 75 mg was administered for the first 2 cycles (28-day cycles), followed by a mandatory reduction to 25 mg BID thereafter for those participants with complete response (CR), partial response (PR) or stable disease (SD), in 28-day cycles (dose determined in Optimization Phase).
|
|---|---|---|---|
|
Dose Optimization Phase
STARTED
|
20
|
13
|
0
|
|
Dose Optimization Phase
Received at Least 1 Dose of Study Drug
|
20
|
13
|
0
|
|
Dose Optimization Phase
COMPLETED
|
0
|
0
|
0
|
|
Dose Optimization Phase
NOT COMPLETED
|
20
|
13
|
0
|
|
Expansion Phase
STARTED
|
0
|
0
|
123
|
|
Expansion Phase
Received at Least 1 Dose of Study Drug
|
0
|
0
|
123
|
|
Expansion Phase
COMPLETED
|
0
|
0
|
0
|
|
Expansion Phase
NOT COMPLETED
|
0
|
0
|
123
|
Reasons for withdrawal
| Measure |
Dose Optimization Phase: Cohort 1
Duvelisib was administered orally (PO) twice daily (BID) at a starting dose of 25 milligrams (mg), with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
|
Dose Optimization Phase: Cohort 2
Duvelisib 75 mg PO BID was administered in 28-day cycles.
|
Expansion Phase
Duvelisib PO BID at a starting dose of 75 mg was administered for the first 2 cycles (28-day cycles), followed by a mandatory reduction to 25 mg BID thereafter for those participants with complete response (CR), partial response (PR) or stable disease (SD), in 28-day cycles (dose determined in Optimization Phase).
|
|---|---|---|---|
|
Dose Optimization Phase
Withdrawal by Subject
|
1
|
1
|
0
|
|
Dose Optimization Phase
Closure Of The Study By The Sponsor
|
3
|
1
|
0
|
|
Dose Optimization Phase
Death
|
16
|
11
|
0
|
|
Expansion Phase
Withdrawal by Subject
|
0
|
0
|
4
|
|
Expansion Phase
Closure Of The Study By The Sponsor
|
0
|
0
|
39
|
|
Expansion Phase
Death
|
0
|
0
|
78
|
|
Expansion Phase
Progressive Disease
|
0
|
0
|
1
|
|
Expansion Phase
Adverse Event
|
0
|
0
|
1
|
Baseline Characteristics
A Study of Duvelisib in Participants With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Baseline characteristics by cohort
| Measure |
Dose Optimization Phase: Cohort 1
n=20 Participants
Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
|
Dose Optimization Phase: Cohort 2
n=13 Participants
Duvelisib 75 mg PO BID, administered in 28-day cycles.
|
Expansion Phase
n=123 Participants
Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those participants with CR, PR or SD, in 28-day cycles (dose determined in Optimization Phase).
|
Total
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 14.81 • n=5 Participants
|
65.0 years
STANDARD_DEVIATION 7.22 • n=7 Participants
|
62.9 years
STANDARD_DEVIATION 13.59 • n=5 Participants
|
63.2 years
STANDARD_DEVIATION 13.29 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
141 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
20 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
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
120 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
49 participants
n=5 Participants
|
62 participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
64 participants
n=5 Participants
|
79 participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
10 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
3
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
4
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
5
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Missing
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 56 days (2 cycles; 28-day cycles)Population: Dose Optimization Efficacy Set: All participants who received at least one dose of study drug, completed at least one cycle of treatment, and had at least one scan to assess disease response after completion of one cycle of treatment. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. As pre-specified, efficacy analysis using investigator assessment reported for the Dose Optimization Phase only.
ORR was defined as the percentage of participants with CR + PR, as assessed by the investigator using the Lugano criteria, for participants receiving the optimal dose of duvelisib for at least one cycle of study therapy.
Outcome measures
| Measure |
Dose Optimization Phase: Cohort 1
n=13 Participants
Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
|
Dose Optimization Phase: Cohort 2
n=13 Participants
Duvelisib 75 mg PO BID, administered in 28-day cycles.
|
Expansion Phase
Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those participants with CR, PR or SD, in 28-day cycles (dose determined in Optimization Phase).
|
|---|---|---|---|
|
Overall Response Rate (ORR) as Assessed by the Investigator Using the Lugano Criteria
|
53.8 percentage of participants
Interval 26.7 to 80.9
|
53.8 percentage of participants
Interval 26.7 to 80.9
|
—
|
PRIMARY outcome
Timeframe: 56 days (2 cycles; 28-day cycles)Population: Modified Intent-to-treat (mITT): all participants who received at least one dose of study drug. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. As pre-specified, efficacy analysis using IRC assessment reported for the Expansion Phase only.
ORR was defined as the percentage of participants with CR + PR, as assessed by the IRC using the Lugano criteria, for participants receiving the optimal dose of duvelisib for at least one cycle of study therapy.
Outcome measures
| Measure |
Dose Optimization Phase: Cohort 1
n=123 Participants
Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
|
Dose Optimization Phase: Cohort 2
Duvelisib 75 mg PO BID, administered in 28-day cycles.
|
Expansion Phase
Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those participants with CR, PR or SD, in 28-day cycles (dose determined in Optimization Phase).
|
|---|---|---|---|
|
ORR as Assessed by the Independent Review Committee (IRC) Using the Lugano Criteria
|
48.0 percentage of participants
Interval 39.1 to 56.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 70 monthsPopulation: Dose Optimization Efficacy Set: All participants who received at least one dose of study drug, completed at least one cycle of treatment, and had at least one scan to assess disease response after completion of one cycle of treatment. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. As pre-specified, efficacy analysis using investigator assessment reported for the Dose Optimization Phase only.
DOR was defined for participants with CR or PR as the time from the date of the first documentation of response (CR or PR) to the date of the first documentation of progressive disease (PD) or death due to any cause. Participants who withdraw from the study for any reason prior to PD and participants who had ongoing response at the time of the data cut were censored at the date of their last response assessment.
Outcome measures
| Measure |
Dose Optimization Phase: Cohort 1
n=5 Participants
Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
|
Dose Optimization Phase: Cohort 2
n=5 Participants
Duvelisib 75 mg PO BID, administered in 28-day cycles.
|
Expansion Phase
Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those participants with CR, PR or SD, in 28-day cycles (dose determined in Optimization Phase).
|
|---|---|---|---|
|
Duration of Response (DOR) as Assessed by the Investigator Using the Lugano Criteria
|
4.22 month
Interval 1.87 to
Insufficient number of participants with events to calculate upper confidence intervals.
|
3.32 month
Interval 1.77 to
Insufficient number of participants with events to calculate upper confidence intervals.
|
—
|
SECONDARY outcome
Timeframe: Up to 70 monthsPopulation: Dose Optimization Efficacy Set: All participants who received at least one dose of study drug, completed at least one cycle of treatment, and had at least one scan to assess disease response after completion of one cycle of treatment. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. As pre-specified, efficacy analysis using investigator assessment reported for the Dose Optimization Phase only.
PFS was defined as the time from the date of first treatment to the date of the first radiographic disease progression or death due to any cause, whichever occurred first.
Outcome measures
| Measure |
Dose Optimization Phase: Cohort 1
n=10 Participants
Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
|
Dose Optimization Phase: Cohort 2
n=11 Participants
Duvelisib 75 mg PO BID, administered in 28-day cycles.
|
Expansion Phase
Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those participants with CR, PR or SD, in 28-day cycles (dose determined in Optimization Phase).
|
|---|---|---|---|
|
Progression-free Survival (PFS) as Assessed by the Investigator Using the Lugano Criteria
|
3.55 month
Interval 1.05 to 8.54
|
3.55 month
Interval 1.81 to 13.14
|
—
|
SECONDARY outcome
Timeframe: Up to 8 weeksPopulation: Dose Optimization Efficacy Set: All participants who received at least one dose of study drug, completed at least one cycle of treatment, and had at least one scan to assess disease response after completion of one cycle of treatment. As pre-specified, efficacy analysis using investigator assessment reported for the Dose Optimization Phase only.
DCR was defined as the percentage of participants with a best overall response of CR or PR or with a best overall response of stable disease (SD) sustained for at least 8 weeks.
Outcome measures
| Measure |
Dose Optimization Phase: Cohort 1
n=13 Participants
Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
|
Dose Optimization Phase: Cohort 2
n=13 Participants
Duvelisib 75 mg PO BID, administered in 28-day cycles.
|
Expansion Phase
Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those participants with CR, PR or SD, in 28-day cycles (dose determined in Optimization Phase).
|
|---|---|---|---|
|
Disease Control Rate (DCR) As Assessed by the Investigator Using the Lugano Criteria
|
61.5 percentage of participants
Interval 35.1 to 88.0
|
61.5 percentage of participants
Interval 35.1 to 88.0
|
—
|
SECONDARY outcome
Timeframe: Up to 70 monthsPopulation: Modified Intent-to-treat (mITT): all participants who receive at least one dose of study drug. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. As pre-specified, efficacy analysis using IRC assessment reported for the Expansion Phase only.
DOR was defined for participants with CR or PR as the time from the date of the first documentation of response (CR or PR) to the date of the first documentation of PD or death due to any cause. Participants who withdrew from the study for any reason prior to PD and participants who had ongoing response at the time of the data cut were censored at the date of their last response assessment.
Outcome measures
| Measure |
Dose Optimization Phase: Cohort 1
n=25 Participants
Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
|
Dose Optimization Phase: Cohort 2
Duvelisib 75 mg PO BID, administered in 28-day cycles.
|
Expansion Phase
Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those participants with CR, PR or SD, in 28-day cycles (dose determined in Optimization Phase).
|
|---|---|---|---|
|
DOR as Assessed by the IRC Using the Lugano Criteria
|
7.9 month
Interval 6.4 to 21.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 70 monthsPopulation: Modified Intent-to-treat (mITT): all participants who received at least one dose of study drug. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. As pre-specified, efficacy analysis using IRC assessment reported for the Expansion Phase only.
PFS was defined as the time from the date of first treatment to the date of the first radiographic disease progression or death due to any cause, whichever occurred first.
Outcome measures
| Measure |
Dose Optimization Phase: Cohort 1
n=74 Participants
Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
|
Dose Optimization Phase: Cohort 2
Duvelisib 75 mg PO BID, administered in 28-day cycles.
|
Expansion Phase
Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those participants with CR, PR or SD, in 28-day cycles (dose determined in Optimization Phase).
|
|---|---|---|---|
|
PFS as Assessed by the IRC Using the Lugano Criteria
|
3.4 months
Interval 1.8 to 3.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 8 weeksPopulation: Modified Intent-to-treat (mITT): all participants who received at least one dose of study drug. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. As pre-specified, efficacy analysis using IRC assessment reported for the Expansion Phase only.
DCR was defined as the percentage of participants with a best overall response of CR or PR or with a best overall response of SD sustained for at least 8 weeks.
Outcome measures
| Measure |
Dose Optimization Phase: Cohort 1
n=123 Participants
Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
|
Dose Optimization Phase: Cohort 2
Duvelisib 75 mg PO BID, administered in 28-day cycles.
|
Expansion Phase
Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those participants with CR, PR or SD, in 28-day cycles (dose determined in Optimization Phase).
|
|---|---|---|---|
|
DCR as Assessed by the IRC Using the Lugano Criteria
|
49.6 percentage of participants
Interval 40.8 to 58.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 70 monthsPopulation: Dose Optimization Efficacy Set: All participants who received at least one dose of study drug, completed at least one cycle of treatment, and had at least one scan to assess disease response after completion of one cycle of treatment. Modified Intent-to-treat (mITT): all participants who receive at least one dose of study drug. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.
OS was defined as the time from the date of first treatment to the date of death due to any cause. Participants without documented death were censored at last alive date.
Outcome measures
| Measure |
Dose Optimization Phase: Cohort 1
n=9 Participants
Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
|
Dose Optimization Phase: Cohort 2
n=11 Participants
Duvelisib 75 mg PO BID, administered in 28-day cycles.
|
Expansion Phase
n=78 Participants
Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those participants with CR, PR or SD, in 28-day cycles (dose determined in Optimization Phase).
|
|---|---|---|---|
|
Overall Survival (OS)
|
6.70 month
Interval 5.22 to
Insufficient number of participants with events to calculate the upper confidence interval.
|
10.58 month
Interval 6.67 to 44.62
|
12.4 month
Interval 8.4 to 22.7
|
SECONDARY outcome
Timeframe: Day 15 of Cycles 1 and 2 (4 hours postdose) (28-day cycles)Population: Safety Analysis Set: all participants who received at least one dose of study drug. Here, 'Overall Number of Participants Analyzed' signifies those who were evaluable for this outcome measure, and 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at the specified time points.
Blood samples were taken for the analyses of duvelisib and IPI-656 in plasma at designated time points. Results are reported as nanograms/milliliter (ng/mL).
Outcome measures
| Measure |
Dose Optimization Phase: Cohort 1
n=14 Participants
Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
|
Dose Optimization Phase: Cohort 2
n=12 Participants
Duvelisib 75 mg PO BID, administered in 28-day cycles.
|
Expansion Phase
n=100 Participants
Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those participants with CR, PR or SD, in 28-day cycles (dose determined in Optimization Phase).
|
|---|---|---|---|
|
Plasma Concentration of IPI-145 (Duvelisib) and IPI-656 (Metabolite)
Duvelisib: Cycle 1, Day 15
|
1238.1 ng/mL
Standard Deviation 787.53
|
2070.0 ng/mL
Standard Deviation 889.39
|
2873.7 ng/mL
Standard Deviation 1709.15
|
|
Plasma Concentration of IPI-145 (Duvelisib) and IPI-656 (Metabolite)
Duvelisib: Cycle 2, Day 15
|
1492.5 ng/mL
Standard Deviation 1019.10
|
—
|
2648.2 ng/mL
Standard Deviation 1336.94
|
|
Plasma Concentration of IPI-145 (Duvelisib) and IPI-656 (Metabolite)
Metabolite (IPI-156): Cycle 1, Day 15
|
1310.4 ng/mL
Standard Deviation 1408.99
|
1580.9 ng/mL
Standard Deviation 772.13
|
2387.5 ng/mL
Standard Deviation 1919.33
|
|
Plasma Concentration of IPI-145 (Duvelisib) and IPI-656 (Metabolite)
Metabolite (IPI-156): Cycle 2, Day 15
|
894.8 ng/mL
Standard Deviation 441.55
|
—
|
2427.0 ng/mL
Standard Deviation 1655.89
|
Adverse Events
Dose Optimization Phase: Cohort 1
Serious events: 14 serious events
Other events: 19 other events
Deaths: 16 deaths
Dose Optimization Phase: Cohort 2
Serious events: 9 serious events
Other events: 13 other events
Deaths: 11 deaths
Expansion Phase
Serious events: 60 serious events
Other events: 121 other events
Deaths: 78 deaths
Serious adverse events
| Measure |
Dose Optimization Phase: Cohort 1
n=20 participants at risk
Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
|
Dose Optimization Phase: Cohort 2
n=13 participants at risk
Duvelisib 75 mg PO BID, administered in 28-day cycles.
|
Expansion Phase
n=123 participants at risk
Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those participants with CR, PR or SD, in 28-day cycles (dose determined in Optimization Phase).
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
1.6%
2/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Cardiac disorders
Sinus tachycardia
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
1.6%
2/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Cardiac disorders
Cardiac arrest
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Cardiac disorders
Tachycardia
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
15.4%
2/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.3%
9/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Gastrointestinal disorders
Colitis
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
15.4%
2/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
1.6%
2/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
General disorders
Disease progression
|
15.0%
3/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
8.1%
10/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
General disorders
Pyrexia
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
23.1%
3/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
4.9%
6/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
General disorders
Multiple organ dysfunction syndrome
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
General disorders
Chills
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
General disorders
General physical health deterioration
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Infections and infestations
Pneumonia
|
20.0%
4/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
3.3%
4/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Infections and infestations
Sepsis
|
15.0%
3/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
2.4%
3/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
1.6%
2/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
1.6%
2/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Infections and infestations
COVID-19
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Infections and infestations
Cellulitis
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Infections and infestations
Coronavirus infection
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Infections and infestations
Cryptococcosis
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Infections and infestations
Febrile infection
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Infections and infestations
Herpes simplex viraemia
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Infections and infestations
Infective spondylitis
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Infections and infestations
Systemic candida
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
2/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
2.4%
3/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
2.4%
3/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Investigations
Platelet count decreased
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
1.6%
2/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
1.6%
2/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epstein-Barr virus associated lymphoproliferative disorder
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Post transplant lymphoproliferative disorder
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Nervous system disorders
Syncope
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Nervous system disorders
Vascular dementia
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
1.6%
2/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
10.0%
2/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
2/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
1.6%
2/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Skin and subcutaneous tissue disorders
Rash morbilliform
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Surgical and medical procedures
Allogenic stem cell transplantation
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Vascular disorders
Hypotension
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Vascular disorders
Embolism
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
Other adverse events
| Measure |
Dose Optimization Phase: Cohort 1
n=20 participants at risk
Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
|
Dose Optimization Phase: Cohort 2
n=13 participants at risk
Duvelisib 75 mg PO BID, administered in 28-day cycles.
|
Expansion Phase
n=123 participants at risk
Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those participants with CR, PR or SD, in 28-day cycles (dose determined in Optimization Phase).
|
|---|---|---|---|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
15.4%
2/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Gastrointestinal disorders
Nausea
|
45.0%
9/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
46.2%
6/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
25.2%
31/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Gastrointestinal disorders
Dysphagia
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
4.1%
5/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
5.7%
7/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Cardiac disorders
Sinus tachycardia
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
15.4%
2/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
5.7%
7/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Cardiac disorders
Tachycardia
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
15.4%
2/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
3.3%
4/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
1.6%
2/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Eye disorders
Cataract
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Eye disorders
Dry eye
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
4.1%
5/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Eye disorders
Eye irritation
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
1.6%
2/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
2/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
30.8%
4/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
10.6%
13/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
5/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
15.4%
2/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
17.9%
22/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Gastrointestinal disorders
Diarrhoea
|
45.0%
9/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
69.2%
9/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
33.3%
41/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
6.5%
8/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
15.4%
2/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.3%
9/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Blood and lymphatic system disorders
Anaemia
|
35.0%
7/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
38.5%
5/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
27.6%
34/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
15.4%
2/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
2.4%
3/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Gastrointestinal disorders
Stomatitis
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
23.1%
3/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
12.2%
15/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Gastrointestinal disorders
Vomiting
|
30.0%
6/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
15.4%
2/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
13.0%
16/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
General disorders
Chills
|
10.0%
2/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
6.5%
8/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
General disorders
Face oedema
|
20.0%
4/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
General disorders
Fatigue
|
35.0%
7/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
46.2%
6/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
30.9%
38/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
General disorders
Generalised oedema
|
10.0%
2/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
General disorders
Malaise
|
10.0%
2/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
2.4%
3/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
General disorders
Oedema peripheral
|
30.0%
6/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
23.1%
3/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
15.4%
19/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
General disorders
Pyrexia
|
30.0%
6/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
46.2%
6/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
22.8%
28/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
General disorders
Swelling face
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Immune system disorders
Drug hypersensitivity
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Infections and infestations
COVID-19
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
5.7%
7/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Infections and infestations
Eye infection
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
15.4%
2/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Infections and infestations
Influenza
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
1.6%
2/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Infections and infestations
Oral candidiasis
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
15.4%
2/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
1.6%
2/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Infections and infestations
Pneumonia
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
4.1%
5/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
4.1%
5/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
4/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
53.8%
7/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
38.2%
47/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Investigations
Amylase increased
|
10.0%
2/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.3%
9/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
4/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
38.5%
5/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
36.6%
45/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Investigations
Blood alkaline phosphatase increased
|
20.0%
4/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
9.8%
12/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Investigations
Blood bilirubin increased
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
8.1%
10/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Investigations
Blood creatinine increased
|
15.0%
3/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
13.0%
16/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Investigations
Blood culture positive
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Investigations
Blood immunoglobulin G decreased
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Investigations
Blood lactate dehydrogenase
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
1.6%
2/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Investigations
Blood lactate dehydrogenase increased
|
10.0%
2/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
16.3%
20/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Investigations
Immunoglobulins decreased
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Investigations
Lipase increased
|
15.0%
3/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
10.6%
13/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Investigations
Lymphocyte count decreased
|
20.0%
4/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
15.4%
2/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
13.8%
17/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Investigations
Neutrophil count decreased
|
40.0%
8/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
23.1%
3/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
33.3%
41/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Investigations
Platelet count decreased
|
55.0%
11/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
46.2%
6/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
27.6%
34/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Investigations
Urine output decreased
|
10.0%
2/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Investigations
Weight decreased
|
15.0%
3/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
23.1%
3/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
6.5%
8/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Investigations
Weight increased
|
10.0%
2/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
3.3%
4/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Investigations
White blood cell count decreased
|
35.0%
7/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
23.1%
3/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
20.3%
25/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
15.4%
2/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
8.9%
11/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
30.8%
4/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
3.3%
4/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
10.0%
2/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
1.6%
2/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
1.6%
2/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
9.8%
12/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
10.0%
2/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
5.7%
7/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.0%
2/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
23.1%
3/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
8.1%
10/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
15.0%
3/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
4.1%
5/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
30.0%
6/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
30.8%
4/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
10.6%
13/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
4.9%
6/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
15.0%
3/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
15.4%
2/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
12.2%
15/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
10.0%
2/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
15.4%
2/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
15.4%
2/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
13.8%
17/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
4/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.3%
9/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
1.6%
2/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
15.4%
2/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
2.4%
3/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
5.7%
7/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.0%
2/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
3.3%
4/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.0%
3/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
4.1%
5/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Nervous system disorders
Dizziness
|
15.0%
3/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
15.4%
2/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.3%
9/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Nervous system disorders
Dysgeusia
|
10.0%
2/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
8.1%
10/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Nervous system disorders
Headache
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
23.1%
3/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
6.5%
8/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Nervous system disorders
Hypoaesthesia
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
1.6%
2/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.3%
9/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
6.5%
8/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Psychiatric disorders
Anxiety
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
15.4%
2/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
4.1%
5/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Psychiatric disorders
Confusional state
|
10.0%
2/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Psychiatric disorders
Insomnia
|
20.0%
4/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
8.1%
10/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Renal and urinary disorders
Acute kidney injury
|
15.0%
3/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
1.6%
2/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
5/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
30.8%
4/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
12.2%
15/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.0%
3/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
13.8%
17/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
1.6%
2/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
2/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
4.9%
6/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
8.9%
11/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
15.4%
2/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
4.1%
5/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
1.6%
2/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
2.4%
3/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
1.6%
2/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
10.0%
2/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
1.6%
2/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
2/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
23.1%
3/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
10.6%
13/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
1.6%
2/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
15.0%
3/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
15.4%
2/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
4.9%
6/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
3.3%
4/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
15.4%
2/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
3.3%
4/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
1.6%
2/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.0%
3/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
23.1%
3/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
16.3%
20/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.0%
3/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
23.1%
3/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
11.4%
14/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
30.8%
4/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
2.4%
3/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.81%
1/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
35.0%
7/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
15.4%
2/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
17.1%
21/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
15.4%
2/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
1.6%
2/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
13.0%
16/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Vascular disorders
Hypotension
|
15.0%
3/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
15.4%
2/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
9.8%
12/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/20 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
7.7%
1/13 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
0.00%
0/123 • From start of treatment (Day 1) to end of study (70 months)
All reported safety data based upon Safety Analysis Set: all participants who received at least one dose of study drug. All-cause mortality reported as occurrence of death due to any cause during the study and after study discontinuation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place