Trial Outcomes & Findings for Study of Luspatercept for the Treatment of Anemia in Patients With Myelodysplastic Syndrome (MDS) (MK-6143-001) (NCT NCT01749514)
NCT ID: NCT01749514
Last Updated: 2024-07-29
Results Overview
The mHI-E for LTB participants was defined as a hemoglobin increase of ≥1.5 g/dL from baseline for ≥14 days or rolling 2 weeks (in the absence of red blood cell \[RBC\] transfusions). Hemoglobin measurements within 7 days following RBC transfusion were excluded from analysis. LTB participants were those who received \<4 units of RBCs within 8 weeks prior to baseline. Rolling 2 weeks was defined as any consecutive 2 weeks during the study. The percentage of LTB participants with mHI-E were reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
116 participants
Primary outcome timeframe
Any consecutive 2 weeks during the study (up to approximately 75 weeks)
Results posted on
2024-07-29
Participant Flow
A total of 116 participants were enrolled and received treatment.
Participant milestones
| Measure |
Luspatercept 0.125mg/kg (Cohort 1)
Participants received luspatercept 0.125mg/kg as a subcutaneous (SC) injection every 3 weeks (Q3W) on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.25mg/kg (Cohort 2)
Participants received luspatercept titrated up to 0.25mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.50mg/kg (Cohort 3)
Participants received luspatercept titrated up to 0.50mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.75mg/kg (Cohort 4)
Participants received luspatercept titrated up to 0.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.00mg/kg (Cohort 5)
Participants received luspatercept titrated up to 1.00mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.33mg/kg (Cohort 6)
Participants received luspatercept titrated up to 1.33mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.75mg/kg (Cohort 7)
Participants received luspatercept titrated up to 1.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Expansion Cohort
Participants received an initial dose of luspatercept 1.0mg/kg SC on Day 1 of the Cycle 1 (Cycle length = 21 days). For each subsequent cycle (up to 5 cycles), the dose was titrated via Fibonacci scheme up to a maximum dose of 1.75mg/kg based on the safety review team (SRT) recommendations.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
6
|
3
|
6
|
3
|
89
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
6
|
3
|
5
|
3
|
82
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
7
|
Reasons for withdrawal
| Measure |
Luspatercept 0.125mg/kg (Cohort 1)
Participants received luspatercept 0.125mg/kg as a subcutaneous (SC) injection every 3 weeks (Q3W) on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.25mg/kg (Cohort 2)
Participants received luspatercept titrated up to 0.25mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.50mg/kg (Cohort 3)
Participants received luspatercept titrated up to 0.50mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.75mg/kg (Cohort 4)
Participants received luspatercept titrated up to 0.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.00mg/kg (Cohort 5)
Participants received luspatercept titrated up to 1.00mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.33mg/kg (Cohort 6)
Participants received luspatercept titrated up to 1.33mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.75mg/kg (Cohort 7)
Participants received luspatercept titrated up to 1.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Expansion Cohort
Participants received an initial dose of luspatercept 1.0mg/kg SC on Day 1 of the Cycle 1 (Cycle length = 21 days). For each subsequent cycle (up to 5 cycles), the dose was titrated via Fibonacci scheme up to a maximum dose of 1.75mg/kg based on the safety review team (SRT) recommendations.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Not Reported
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
Baseline Characteristics
All enrolled participants with baseline hemoglobin level data available. Data were not collected from 3 participants at baseline.
Baseline characteristics by cohort
| Measure |
Luspatercept 0.125mg/kg (Cohort 1)
n=3 Participants
Participants received luspatercept 0.125mg/kg as a subcutaneous (SC) injection every 3 weeks (Q3W) on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.25mg/kg (Cohort 2)
n=3 Participants
Participants received luspatercept titrated up to 0.25mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.50mg/kg (Cohort 3)
n=3 Participants
Participants received luspatercept titrated up to 0.50mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.75mg/kg (Cohort 4)
n=6 Participants
Participants received luspatercept titrated up to 0.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.00mg/kg (Cohort 5)
n=3 Participants
Participants received luspatercept titrated up to 1.00mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.33mg/kg (Cohort 6)
n=6 Participants
Participants received luspatercept titrated up to 1.33mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.75mg/kg (Cohort 7)
n=3 Participants
Participants received luspatercept titrated up to 1.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Expansion Cohort
n=89 Participants
Participants received an initial dose of luspatercept 1.0mg/kg SC on Day 1 of the Cycle 1 (Cycle length = 21 days). For each subsequent cycle (up to 5 cycles), the dose was titrated via Fibonacci scheme up to a maximum dose of 1.75mg/kg based on the safety review team (SRT) recommendations.
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
70.0 years
STANDARD_DEVIATION 19.1 • n=3 Participants
|
59.0 years
STANDARD_DEVIATION 27.8 • n=3 Participants
|
66.3 years
STANDARD_DEVIATION 5.1 • n=3 Participants
|
64.8 years
STANDARD_DEVIATION 11.3 • n=6 Participants
|
73.7 years
STANDARD_DEVIATION 3.8 • n=3 Participants
|
68.2 years
STANDARD_DEVIATION 7.1 • n=6 Participants
|
63.7 years
STANDARD_DEVIATION 19.6 • n=3 Participants
|
71.6 years
STANDARD_DEVIATION 9.6 • n=89 Participants
|
70.4 years
STANDARD_DEVIATION 10.7 • n=116 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=3 Participants
|
30 Participants
n=89 Participants
|
44 Participants
n=116 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
59 Participants
n=89 Participants
|
72 Participants
n=116 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=89 Participants
|
0 Participants
n=116 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
3 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
3 Participants
n=3 Participants
|
80 Participants
n=89 Participants
|
105 Participants
n=116 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
9 Participants
n=89 Participants
|
11 Participants
n=116 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=89 Participants
|
0 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=89 Participants
|
0 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=89 Participants
|
0 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=89 Participants
|
0 Participants
n=116 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
3 Participants
n=3 Participants
|
89 Participants
n=89 Participants
|
116 Participants
n=116 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=89 Participants
|
0 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=89 Participants
|
0 Participants
n=116 Participants
|
|
Transfusion Status
HTB
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
31 Participants
n=89 Participants
|
51 Participants
n=116 Participants
|
|
Transfusion Status
LTB
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=3 Participants
|
58 Participants
n=89 Participants
|
65 Participants
n=116 Participants
|
|
Hemoglobin level
|
10.30 g/dl
STANDARD_DEVIATION 0.98 • n=3 Participants • All enrolled participants with baseline hemoglobin level data available. Data were not collected from 3 participants at baseline.
|
8.91 g/dl
STANDARD_DEVIATION 0.81 • n=3 Participants • All enrolled participants with baseline hemoglobin level data available. Data were not collected from 3 participants at baseline.
|
8.83 g/dl
STANDARD_DEVIATION 0.31 • n=3 Participants • All enrolled participants with baseline hemoglobin level data available. Data were not collected from 3 participants at baseline.
|
8.55 g/dl
STANDARD_DEVIATION 0.75 • n=6 Participants • All enrolled participants with baseline hemoglobin level data available. Data were not collected from 3 participants at baseline.
|
8.37 g/dl
STANDARD_DEVIATION 1.10 • n=3 Participants • All enrolled participants with baseline hemoglobin level data available. Data were not collected from 3 participants at baseline.
|
8.42 g/dl
STANDARD_DEVIATION 0.58 • n=5 Participants • All enrolled participants with baseline hemoglobin level data available. Data were not collected from 3 participants at baseline.
|
9.53 g/dl
STANDARD_DEVIATION 0.06 • n=3 Participants • All enrolled participants with baseline hemoglobin level data available. Data were not collected from 3 participants at baseline.
|
8.79 g/dl
STANDARD_DEVIATION 1.01 • n=87 Participants • All enrolled participants with baseline hemoglobin level data available. Data were not collected from 3 participants at baseline.
|
8.81 g/dl
STANDARD_DEVIATION 0.98 • n=113 Participants • All enrolled participants with baseline hemoglobin level data available. Data were not collected from 3 participants at baseline.
|
PRIMARY outcome
Timeframe: Any consecutive 2 weeks during the study (up to approximately 75 weeks)Population: All enrolled LTB participants who received at least one dose of luspatercept and received \<4 units of RBCs within 8 weeks prior to baseline.
The mHI-E for LTB participants was defined as a hemoglobin increase of ≥1.5 g/dL from baseline for ≥14 days or rolling 2 weeks (in the absence of red blood cell \[RBC\] transfusions). Hemoglobin measurements within 7 days following RBC transfusion were excluded from analysis. LTB participants were those who received \<4 units of RBCs within 8 weeks prior to baseline. Rolling 2 weeks was defined as any consecutive 2 weeks during the study. The percentage of LTB participants with mHI-E were reported.
Outcome measures
| Measure |
Luspatercept 1.75mg/kg (Cohort 7)
n=2 Participants
Participants received luspatercept titrated up to 1.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Expansion Cohort
n=58 Participants
Participants received an initial dose of luspatercept 1.0mg/kg SC on Day 1 of the Cycle 1 (Cycle length = 21 days). For each subsequent cycle (up to 5 cycles), the dose was titrated via Fibonacci scheme up to a maximum dose of 1.75mg/kg based on the safety review team (SRT) recommendations.
|
Luspatercept 0.125mg/kg (Cohort 1)
n=1 Participants
Participants received luspatercept 0.125mg/kg as a subcutaneous (SC) injection every 3 weeks (Q3W) on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.25mg/kg (Cohort 2)
n=1 Participants
Participants received luspatercept titrated up to 0.25mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.50mg/kg (Cohort 3)
Participants received luspatercept titrated up to 0.50mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.75mg/kg (Cohort 4)
n=3 Participants
Participants received luspatercept titrated up to 0.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.00mg/kg (Cohort 5)
Participants received luspatercept titrated up to 1.00mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.33mg/kg (Cohort 6)
Participants received luspatercept titrated up to 1.33mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Low Transfusion Burden (LTB) Participants With Modified Erythroid Response (mHI-E)
|
100 Percentage of participants
Interval 15.8 to 100.0
|
69.0 Percentage of participants
Interval 55.5 to 80.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
—
|
66.7 Percentage of participants
Interval 9.4 to 99.2
|
—
|
—
|
PRIMARY outcome
Timeframe: Any consecutive 8 weeks during the study (up to approximately 75 weeks)Population: All enrolled HTB participants who received at least one dose of luspatercept and who required ≥4 units of RBC transfusions within 8 weeks prior to baseline.
The mHI-E for HTB participants was defined as a ≥4 units or ≥50% reduction in RBC transfusion burden during any rolling 8-week window compared to baseline. HTB participants were those who required ≥4 units of RBC transfusions within 8 weeks prior to baseline. Rolling 8 weeks was defined as any consecutive 8 weeks during the study. The percentage of HTB participants with mHI-E were reported.
Outcome measures
| Measure |
Luspatercept 1.75mg/kg (Cohort 7)
n=1 Participants
Participants received luspatercept titrated up to 1.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Expansion Cohort
n=31 Participants
Participants received an initial dose of luspatercept 1.0mg/kg SC on Day 1 of the Cycle 1 (Cycle length = 21 days). For each subsequent cycle (up to 5 cycles), the dose was titrated via Fibonacci scheme up to a maximum dose of 1.75mg/kg based on the safety review team (SRT) recommendations.
|
Luspatercept 0.125mg/kg (Cohort 1)
n=2 Participants
Participants received luspatercept 0.125mg/kg as a subcutaneous (SC) injection every 3 weeks (Q3W) on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.25mg/kg (Cohort 2)
n=2 Participants
Participants received luspatercept titrated up to 0.25mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.50mg/kg (Cohort 3)
n=3 Participants
Participants received luspatercept titrated up to 0.50mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.75mg/kg (Cohort 4)
n=3 Participants
Participants received luspatercept titrated up to 0.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.00mg/kg (Cohort 5)
n=3 Participants
Participants received luspatercept titrated up to 1.00mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.33mg/kg (Cohort 6)
n=6 Participants
Participants received luspatercept titrated up to 1.33mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of High Transfusion Burden (HTB) Participants With mHI-E
|
100 Percentage of Participants
Interval 2.5 to 100.0
|
54.8 Percentage of Participants
Interval 36.0 to 72.7
|
50.0 Percentage of Participants
Interval 1.26 to 98.7
|
50.0 Percentage of Participants
Interval 1.26 to 98.7
|
33.3 Percentage of Participants
Interval 0.84 to 90.6
|
33.3 Percentage of Participants
Interval 0.84 to 90.6
|
33.3 Percentage of Participants
Interval 0.84 to 90.6
|
50.0 Percentage of Participants
Interval 11.8 to 88.2
|
SECONDARY outcome
Timeframe: Up to approximately 24 weeksPopulation: All enrolled participants who received at least one dose of luspatercept.
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a study drug, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The number of participants who experienced an AE were reported.
Outcome measures
| Measure |
Luspatercept 1.75mg/kg (Cohort 7)
n=3 Participants
Participants received luspatercept titrated up to 1.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Expansion Cohort
n=89 Participants
Participants received an initial dose of luspatercept 1.0mg/kg SC on Day 1 of the Cycle 1 (Cycle length = 21 days). For each subsequent cycle (up to 5 cycles), the dose was titrated via Fibonacci scheme up to a maximum dose of 1.75mg/kg based on the safety review team (SRT) recommendations.
|
Luspatercept 0.125mg/kg (Cohort 1)
n=3 Participants
Participants received luspatercept 0.125mg/kg as a subcutaneous (SC) injection every 3 weeks (Q3W) on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.25mg/kg (Cohort 2)
n=3 Participants
Participants received luspatercept titrated up to 0.25mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.50mg/kg (Cohort 3)
n=3 Participants
Participants received luspatercept titrated up to 0.50mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.75mg/kg (Cohort 4)
n=6 Participants
Participants received luspatercept titrated up to 0.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.00mg/kg (Cohort 5)
n=3 Participants
Participants received luspatercept titrated up to 1.00mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.33mg/kg (Cohort 6)
n=6 Participants
Participants received luspatercept titrated up to 1.33mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE)
|
2 Participants
|
75 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 12 weeksPopulation: All enrolled participants who received at least one dose of luspatercept.
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a study drug, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The number of participants who discontinued study treatment due to an AE were reported.
Outcome measures
| Measure |
Luspatercept 1.75mg/kg (Cohort 7)
n=3 Participants
Participants received luspatercept titrated up to 1.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Expansion Cohort
n=89 Participants
Participants received an initial dose of luspatercept 1.0mg/kg SC on Day 1 of the Cycle 1 (Cycle length = 21 days). For each subsequent cycle (up to 5 cycles), the dose was titrated via Fibonacci scheme up to a maximum dose of 1.75mg/kg based on the safety review team (SRT) recommendations.
|
Luspatercept 0.125mg/kg (Cohort 1)
n=3 Participants
Participants received luspatercept 0.125mg/kg as a subcutaneous (SC) injection every 3 weeks (Q3W) on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.25mg/kg (Cohort 2)
n=3 Participants
Participants received luspatercept titrated up to 0.25mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.50mg/kg (Cohort 3)
n=3 Participants
Participants received luspatercept titrated up to 0.50mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.75mg/kg (Cohort 4)
n=6 Participants
Participants received luspatercept titrated up to 0.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.00mg/kg (Cohort 5)
n=3 Participants
Participants received luspatercept titrated up to 1.00mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.33mg/kg (Cohort 6)
n=6 Participants
Participants received luspatercept titrated up to 1.33mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Due To an AE
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Any consecutive 8 Weeks during the study treatment (up to approximately 75 weeks)Population: All enrolled participants who received at least one dose of luspatercept.
Per IWG 2006 response criteria, rate of HI-E is defined as the percentage of participants for whom the mean of all hemoglobin value from baseline during any rolling 8-week increased ≥1.5 g/dL in the absence of transfusion for LTB participants, or a reduction by ≥4 units of RBCs transfusion over any rolling 8-week window for HTB patients. LTB participants were those who received \<4 units of RBCs within 8 weeks prior to baseline. HTB participants were those who required ≥4 units of RBC transfusions within 8 weeks prior to baseline. Rolling 8 weeks was defined as any consecutive 8 weeks during the study.
Outcome measures
| Measure |
Luspatercept 1.75mg/kg (Cohort 7)
n=3 Participants
Participants received luspatercept titrated up to 1.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Expansion Cohort
n=89 Participants
Participants received an initial dose of luspatercept 1.0mg/kg SC on Day 1 of the Cycle 1 (Cycle length = 21 days). For each subsequent cycle (up to 5 cycles), the dose was titrated via Fibonacci scheme up to a maximum dose of 1.75mg/kg based on the safety review team (SRT) recommendations.
|
Luspatercept 0.125mg/kg (Cohort 1)
n=3 Participants
Participants received luspatercept 0.125mg/kg as a subcutaneous (SC) injection every 3 weeks (Q3W) on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.25mg/kg (Cohort 2)
n=3 Participants
Participants received luspatercept titrated up to 0.25mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.50mg/kg (Cohort 3)
n=3 Participants
Participants received luspatercept titrated up to 0.50mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.75mg/kg (Cohort 4)
n=6 Participants
Participants received luspatercept titrated up to 0.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.00mg/kg (Cohort 5)
n=3 Participants
Participants received luspatercept titrated up to 1.00mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.33mg/kg (Cohort 6)
n=6 Participants
Participants received luspatercept titrated up to 1.33mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
|---|---|---|---|---|---|---|---|---|
|
Rate of Erythroid Response (HI-E) Per International Working Group (IWG) 2006 Response Criteria
|
100 Percentage of participants
Interval 29.2 to 100.0
|
53.9 Percentage of participants
Interval 43.0 to 64.6
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
0 Percentage of participants
Interval 0.0 to 70.8
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
33.3 Percentage of participants
Interval 4.3 to 77.7
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
50.0 Percentage of participants
Interval 11.8 to 88.2
|
SECONDARY outcome
Timeframe: Any consecutive 8 Weeks during the study treatment (up to approximately 75 weeks)Population: All enrolled participants who received at least one dose of luspatercept and had baseline platelet count \<100x10\^9/L.
Per IWG 2006 response criteria, HI-P was defined for participants with baseline value ≥20 x 10\^9/L as the platelet increase in any rolling 8 weeks ≥30 x 10\^9 and for participants with baseline value \<20 x 10\^9/L as the platelet increase in any rolling 8 weeks \>20 x 10\^9/L with increase of at least 100%. The rolling 8-week was defined as any consecutive 8 weeks during the study. The percentage of participants with HI-P were reported.
Outcome measures
| Measure |
Luspatercept 1.75mg/kg (Cohort 7)
Participants received luspatercept titrated up to 1.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Expansion Cohort
n=17 Participants
Participants received an initial dose of luspatercept 1.0mg/kg SC on Day 1 of the Cycle 1 (Cycle length = 21 days). For each subsequent cycle (up to 5 cycles), the dose was titrated via Fibonacci scheme up to a maximum dose of 1.75mg/kg based on the safety review team (SRT) recommendations.
|
Luspatercept 0.125mg/kg (Cohort 1)
Participants received luspatercept 0.125mg/kg as a subcutaneous (SC) injection every 3 weeks (Q3W) on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.25mg/kg (Cohort 2)
Participants received luspatercept titrated up to 0.25mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.50mg/kg (Cohort 3)
n=1 Participants
Participants received luspatercept titrated up to 0.50mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.75mg/kg (Cohort 4)
Participants received luspatercept titrated up to 0.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.00mg/kg (Cohort 5)
n=2 Participants
Participants received luspatercept titrated up to 1.00mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.33mg/kg (Cohort 6)
n=1 Participants
Participants received luspatercept titrated up to 1.33mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
|---|---|---|---|---|---|---|---|---|
|
Rate of Platelet Response (HI-P) Per IWG 2006 Criteria
|
—
|
23.5 Percentage of participants
95% Confidence Interval 6.8 • Interval 6.8 to 49.9
|
—
|
—
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
—
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 84.2
|
0 Percentage of participants
95% Confidence Interval 0.0 • Interval 0.0 to 97.5
|
SECONDARY outcome
Timeframe: Any consecutive 8 Weeks during the study treatment (up to approximately 75 weeks)Population: All enrolled participants who received at least one dose of luspatercept and had baseline neutrophil count \<1.0×10\^9/L.
Per IWG 2006 response criteria, HI-N was defined as the neutrophil increase in any rolling 8 weeks is at last 100% and an absolute increase \> 0.5 x 10\^9/L. The rolling 8-week was defined as any consecutive 8 weeks during the study. The percentage of participants with HI-N response were reported.
Outcome measures
| Measure |
Luspatercept 1.75mg/kg (Cohort 7)
n=1 Participants
Participants received luspatercept titrated up to 1.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Expansion Cohort
n=18 Participants
Participants received an initial dose of luspatercept 1.0mg/kg SC on Day 1 of the Cycle 1 (Cycle length = 21 days). For each subsequent cycle (up to 5 cycles), the dose was titrated via Fibonacci scheme up to a maximum dose of 1.75mg/kg based on the safety review team (SRT) recommendations.
|
Luspatercept 0.125mg/kg (Cohort 1)
n=1 Participants
Participants received luspatercept 0.125mg/kg as a subcutaneous (SC) injection every 3 weeks (Q3W) on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.25mg/kg (Cohort 2)
Participants received luspatercept titrated up to 0.25mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.50mg/kg (Cohort 3)
n=1 Participants
Participants received luspatercept titrated up to 0.50mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.75mg/kg (Cohort 4)
n=1 Participants
Participants received luspatercept titrated up to 0.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.00mg/kg (Cohort 5)
Participants received luspatercept titrated up to 1.00mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.33mg/kg (Cohort 6)
n=3 Participants
Participants received luspatercept titrated up to 1.33mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
|---|---|---|---|---|---|---|---|---|
|
Rate of Neutrophil Response (HI-N) Per IWG 2006 Criteria
|
100 Percentage of Participants
Interval 2.5 to 100.0
|
25.0 Percentage of Participants
Interval 8.7 to 49.1
|
0 Percentage of Participants
Interval 0.0 to 97.5
|
—
|
100 Percentage of Participants
Interval 2.5 to 100.0
|
0 Percentage of Participants
Interval 0.0 to 97.5
|
—
|
66.7 Percentage of Participants
Interval 9.4 to 99.2
|
SECONDARY outcome
Timeframe: up to approximately 75 weeksPopulation: All enrolled participants who received at least one dose of luspatercept. Per protocol, the participants with response were pooled into low and high dose groups to increase the accuracy of the analyses.
Per IWG 2006 response criteria, duration of HI-E response was defined as the time from the first day of the first rolling 8-week interval of showing response to the last day of the last consecutive rolling 8-week interval of showing response. HI-E response for LTB participants was defined as hemoglobin increase ≥ 1.5 g/dL during any rolling 8-week window and for HTB HI-E was defined as RBC transfusion reduction ≥4 units during any rolling 8 weeks. LTB participants were those who received \<4 units of RBCs within 8 weeks prior to baseline. HTB participants were those who required ≥4 units of RBC transfusions within 8 weeks prior to baseline. The rolling 8-week was defined as any consecutive 8 weeks during the study.
Outcome measures
| Measure |
Luspatercept 1.75mg/kg (Cohort 7)
Participants received luspatercept titrated up to 1.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Expansion Cohort
Participants received an initial dose of luspatercept 1.0mg/kg SC on Day 1 of the Cycle 1 (Cycle length = 21 days). For each subsequent cycle (up to 5 cycles), the dose was titrated via Fibonacci scheme up to a maximum dose of 1.75mg/kg based on the safety review team (SRT) recommendations.
|
Luspatercept 0.125mg/kg (Cohort 1)
n=9 Participants
Participants received luspatercept 0.125mg/kg as a subcutaneous (SC) injection every 3 weeks (Q3W) on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.25mg/kg (Cohort 2)
n=107 Participants
Participants received luspatercept titrated up to 0.25mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.50mg/kg (Cohort 3)
Participants received luspatercept titrated up to 0.50mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.75mg/kg (Cohort 4)
Participants received luspatercept titrated up to 0.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.00mg/kg (Cohort 5)
Participants received luspatercept titrated up to 1.00mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.33mg/kg (Cohort 6)
Participants received luspatercept titrated up to 1.33mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
|---|---|---|---|---|---|---|---|---|
|
Duration of HI-E Per IWG 2006 Response Criteria
|
—
|
—
|
78 Days
Standard Deviation 7.8
|
88 Days
Standard Deviation 22.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Any consecutive 8 weeks during the study (up to approximately 75 weeks)Population: All enrolled participants who received at least one dose of luspatercept. Per protocol, the participants with response were pooled into low and high dose groups to increase the accuracy of the analyses.
Per IWG 2006 response criteria, the time to HI-E response was defined as the first date of the rolling 8-week interval of showing response minus first dose date plus 1. HI-E response for LTB participants was defined as hemoglobin increase ≥ 1.5 g/dL during any rolling 8 weeks window and for HTB HI-E was defined as RBC transfusion reduction ≥4 units during any rolling 8 weeks. LTB participants were those who received \<4 units of RBCs within 8 weeks prior to baseline. HTB participants were those who required ≥4 units of RBC transfusions within 8 weeks prior to baseline. The rolling 8-week was defined as any consecutive 8 weeks during the study.
Outcome measures
| Measure |
Luspatercept 1.75mg/kg (Cohort 7)
Participants received luspatercept titrated up to 1.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Expansion Cohort
Participants received an initial dose of luspatercept 1.0mg/kg SC on Day 1 of the Cycle 1 (Cycle length = 21 days). For each subsequent cycle (up to 5 cycles), the dose was titrated via Fibonacci scheme up to a maximum dose of 1.75mg/kg based on the safety review team (SRT) recommendations.
|
Luspatercept 0.125mg/kg (Cohort 1)
n=9 Participants
Participants received luspatercept 0.125mg/kg as a subcutaneous (SC) injection every 3 weeks (Q3W) on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.25mg/kg (Cohort 2)
n=107 Participants
Participants received luspatercept titrated up to 0.25mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.50mg/kg (Cohort 3)
Participants received luspatercept titrated up to 0.50mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.75mg/kg (Cohort 4)
Participants received luspatercept titrated up to 0.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.00mg/kg (Cohort 5)
Participants received luspatercept titrated up to 1.00mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.33mg/kg (Cohort 6)
Participants received luspatercept titrated up to 1.33mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
|---|---|---|---|---|---|---|---|---|
|
Time to HI-E Per IWG 2006 Response Criteria
|
—
|
—
|
35 Days
Standard Deviation 48.1
|
17 Days
Standard Deviation 18.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (prior to first dose of luspatercept) and Day 113Population: All enrolled HTB participants who received at least one dose of luspatercept and who required ≥4 units of RBC transfusions within 8 weeks prior to baseline.
Frequency of RBC transfusion was defined as the total number of RBC transfusions received. Per protocol, the mean change from baseline to Day 113 in frequency of RBC transfusion was reported in the HTB participants (those who required ≥4 units of RBC transfusions within 8 weeks prior to baseline).
Outcome measures
| Measure |
Luspatercept 1.75mg/kg (Cohort 7)
n=1 Participants
Participants received luspatercept titrated up to 1.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Expansion Cohort
n=31 Participants
Participants received an initial dose of luspatercept 1.0mg/kg SC on Day 1 of the Cycle 1 (Cycle length = 21 days). For each subsequent cycle (up to 5 cycles), the dose was titrated via Fibonacci scheme up to a maximum dose of 1.75mg/kg based on the safety review team (SRT) recommendations.
|
Luspatercept 0.125mg/kg (Cohort 1)
n=2 Participants
Participants received luspatercept 0.125mg/kg as a subcutaneous (SC) injection every 3 weeks (Q3W) on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.25mg/kg (Cohort 2)
n=2 Participants
Participants received luspatercept titrated up to 0.25mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.50mg/kg (Cohort 3)
n=3 Participants
Participants received luspatercept titrated up to 0.50mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.75mg/kg (Cohort 4)
n=3 Participants
Participants received luspatercept titrated up to 0.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.00mg/kg (Cohort 5)
n=3 Participants
Participants received luspatercept titrated up to 1.00mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.33mg/kg (Cohort 6)
n=6 Participants
Participants received luspatercept titrated up to 1.33mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline to Day 113 in Frequency of RBC Transfusions
Baseline to Day 113
|
-2.46 Number of RBC transfusions
Standard Deviation NA
NA = SD could not be calculated due to low number of participants with RBC transfusion.
|
-0.85 Number of RBC transfusions
Standard Deviation 1.14
|
-0.70 Number of RBC transfusions
Standard Deviation 0.71
|
0.11 Number of RBC transfusions
Standard Deviation 0.69
|
0.38 Number of RBC transfusions
Standard Deviation 2.08
|
0.40 Number of RBC transfusions
Standard Deviation 2.12
|
-0.31 Number of RBC transfusions
Standard Deviation 1.21
|
-0.36 Number of RBC transfusions
Standard Deviation 1.03
|
|
Mean Change From Baseline to Day 113 in Frequency of RBC Transfusions
Baseline
|
3.00 Number of RBC transfusions
Standard Deviation NA
NA = SD could not be calculated due to low number of participants with RBC transfusion.
|
3.06 Number of RBC transfusions
Standard Deviation 1.34
|
2.50 Number of RBC transfusions
Standard Deviation 0.71
|
2.50 Number of RBC transfusions
Standard Deviation 2.12
|
4.00 Number of RBC transfusions
Standard Deviation 0.00
|
2.00 Number of RBC transfusions
Standard Deviation 0.00
|
4.00 Number of RBC transfusions
Standard Deviation 1.00
|
2.83 Number of RBC transfusions
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: Up to approximately 16 weeksPopulation: All enrolled HTB participants who received at least one dose of luspatercept and had ≥2 units of RBC transfusions at baseline.
Rate of RBC-TI was defined as percentage of participants with ≥2 units of RBC transfusions at baseline who experienced transfusion independence which was defined as ≥8 weeks without a transfusion while on treatment. Per protocol, rate of RBC-TI was reported in HTB participants (those who required ≥4 units of RBC transfusions within 8 weeks prior to baseline).
Outcome measures
| Measure |
Luspatercept 1.75mg/kg (Cohort 7)
n=1 Participants
Participants received luspatercept titrated up to 1.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Expansion Cohort
n=57 Participants
Participants received an initial dose of luspatercept 1.0mg/kg SC on Day 1 of the Cycle 1 (Cycle length = 21 days). For each subsequent cycle (up to 5 cycles), the dose was titrated via Fibonacci scheme up to a maximum dose of 1.75mg/kg based on the safety review team (SRT) recommendations.
|
Luspatercept 0.125mg/kg (Cohort 1)
n=2 Participants
Participants received luspatercept 0.125mg/kg as a subcutaneous (SC) injection every 3 weeks (Q3W) on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.25mg/kg (Cohort 2)
n=2 Participants
Participants received luspatercept titrated up to 0.25mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.50mg/kg (Cohort 3)
n=3 Participants
Participants received luspatercept titrated up to 0.50mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.75mg/kg (Cohort 4)
n=6 Participants
Participants received luspatercept titrated up to 0.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.00mg/kg (Cohort 5)
n=3 Participants
Participants received luspatercept titrated up to 1.00mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.33mg/kg (Cohort 6)
n=6 Participants
Participants received luspatercept titrated up to 1.33mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
|---|---|---|---|---|---|---|---|---|
|
Rate of RBC Transfusion Independence (RBC-TI)
|
100 Percentage of participants
Interval 2.5 to 100.0
|
43.9 Percentage of participants
Interval 30.7 to 57.6
|
50.0 Percentage of participants
Interval 1.3 to 98.7
|
0.0 Percentage of participants
Interval 0.0 to 84.2
|
0.0 Percentage of participants
Interval 0.0 to 70.8
|
66.7 Percentage of participants
Interval 22.3 to 95.7
|
0 Percentage of participants
Interval 0.0 to 70.8
|
33.3 Percentage of participants
Interval 4.3 to 77.7
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: Predose, Cycle 1: Days 8, 11, 15: Postdose; Cycle 2 Day 1, Cycle 2 Day 8, Cycle 4 Day 1, Cycle 5 Day 1, and Cycle 5 Days 8, 15: Postdose (each cycle length = 21 days)Population: All participants who have received at least one dose of luspatercept and had sufficient pharmacokinetic samples collected and assayed.
Blood samples were collected at specified intervals for the determination of Tmax. Tmax was defined as time to the maximum concentration of luspatercept reached. Tmax was based on non-compartmental analysis and a mean Tmax value was presented.
Outcome measures
| Measure |
Luspatercept 1.75mg/kg (Cohort 7)
n=3 Participants
Participants received luspatercept titrated up to 1.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Expansion Cohort
n=89 Participants
Participants received an initial dose of luspatercept 1.0mg/kg SC on Day 1 of the Cycle 1 (Cycle length = 21 days). For each subsequent cycle (up to 5 cycles), the dose was titrated via Fibonacci scheme up to a maximum dose of 1.75mg/kg based on the safety review team (SRT) recommendations.
|
Luspatercept 0.125mg/kg (Cohort 1)
n=3 Participants
Participants received luspatercept 0.125mg/kg as a subcutaneous (SC) injection every 3 weeks (Q3W) on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.25mg/kg (Cohort 2)
n=3 Participants
Participants received luspatercept titrated up to 0.25mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.50mg/kg (Cohort 3)
n=3 Participants
Participants received luspatercept titrated up to 0.50mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.75mg/kg (Cohort 4)
n=6 Participants
Participants received luspatercept titrated up to 0.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.00mg/kg (Cohort 5)
n=3 Participants
Participants received luspatercept titrated up to 1.00mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.33mg/kg (Cohort 6)
n=6 Participants
Participants received luspatercept titrated up to 1.33mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Concentration (Tmax) of Luspatercept
|
6.65 Days
Geometric Coefficient of Variation 8.92
|
7.77 Days
Geometric Coefficient of Variation 21.76
|
9.93 Days
Geometric Coefficient of Variation 35.73
|
7.23 Days
Geometric Coefficient of Variation 20.68
|
10.16 Days
Geometric Coefficient of Variation 39.56
|
7.16 Days
Geometric Coefficient of Variation 5.46
|
7.23 Days
Geometric Coefficient of Variation 20.68
|
8.47 Days
Geometric Coefficient of Variation 31.58
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: Predose, Cycle 1: Days 8, 11, 15: Postdose; Cycle 2 Day 1, Cycle 2 Day 8, Cycle 4 Day 1, Cycle 5 Day 1, and Cycle 5 Days 8, 15: Postdose (each cycle length = 21 days)Population: All participants who received at least one dose of luspatercept and had sufficient pharmacokinetic samples collected and assayed.
Blood samples were collected at specified intervals for the determination of t½. t½ was defined as the time required to divide the luspatercept plasma concentration by two after reaching pseudo-equilibrium, following a single dose of luspatercept. t½ was based on non-compartmental analysis and a mean t1/2 value was presented.
Outcome measures
| Measure |
Luspatercept 1.75mg/kg (Cohort 7)
n=1 Participants
Participants received luspatercept titrated up to 1.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Expansion Cohort
n=62 Participants
Participants received an initial dose of luspatercept 1.0mg/kg SC on Day 1 of the Cycle 1 (Cycle length = 21 days). For each subsequent cycle (up to 5 cycles), the dose was titrated via Fibonacci scheme up to a maximum dose of 1.75mg/kg based on the safety review team (SRT) recommendations.
|
Luspatercept 0.125mg/kg (Cohort 1)
n=2 Participants
Participants received luspatercept 0.125mg/kg as a subcutaneous (SC) injection every 3 weeks (Q3W) on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.25mg/kg (Cohort 2)
n=3 Participants
Participants received luspatercept titrated up to 0.25mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.50mg/kg (Cohort 3)
n=3 Participants
Participants received luspatercept titrated up to 0.50mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.75mg/kg (Cohort 4)
n=6 Participants
Participants received luspatercept titrated up to 0.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.00mg/kg (Cohort 5)
n=3 Participants
Participants received luspatercept titrated up to 1.00mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.33mg/kg (Cohort 6)
n=5 Participants
Participants received luspatercept titrated up to 1.33mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
|---|---|---|---|---|---|---|---|---|
|
Terminal Half-Life (t ½) of Luspatercept
|
26.56 Days
Geometric Coefficient of Variation 9.19
|
14.74 Days
Geometric Coefficient of Variation 44.35
|
23.78 Days
Geometric Coefficient of Variation 22.29
|
9.15 Days
Geometric Coefficient of Variation 44.83
|
15.14 Days
Geometric Coefficient of Variation 5.94
|
14.45 Days
Geometric Coefficient of Variation 16.02
|
13.75 Days
Geometric Coefficient of Variation 7.37
|
14.76 Days
Geometric Coefficient of Variation 24.43
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: Predose, Cycle 1: Days 8, 11, 15: Postdose; Cycle 2 Day 1, Cycle 2 Day 8, Cycle 4 Day 1, Cycle 5 Day 1, and Cycle 5 Days 8, 15: Postdose (each cycle length = 21 days)Population: All participants who received at least one dose of luspatercept and had sufficient pharmacokinetic samples collected and assayed.
Blood samples were collected at specified intervals for the determination of Cmax. Cmax was defined as the maximum concentration of luspatercept reached. Cmax was based on non-compartmental analysis and a mean Cmax value was presented.
Outcome measures
| Measure |
Luspatercept 1.75mg/kg (Cohort 7)
n=3 Participants
Participants received luspatercept titrated up to 1.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Expansion Cohort
n=89 Participants
Participants received an initial dose of luspatercept 1.0mg/kg SC on Day 1 of the Cycle 1 (Cycle length = 21 days). For each subsequent cycle (up to 5 cycles), the dose was titrated via Fibonacci scheme up to a maximum dose of 1.75mg/kg based on the safety review team (SRT) recommendations.
|
Luspatercept 0.125mg/kg (Cohort 1)
n=3 Participants
Participants received luspatercept 0.125mg/kg as a subcutaneous (SC) injection every 3 weeks (Q3W) on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.25mg/kg (Cohort 2)
n=3 Participants
Participants received luspatercept titrated up to 0.25mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.50mg/kg (Cohort 3)
n=3 Participants
Participants received luspatercept titrated up to 0.50mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.75mg/kg (Cohort 4)
n=6 Participants
Participants received luspatercept titrated up to 0.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.00mg/kg (Cohort 5)
n=3 Participants
Participants received luspatercept titrated up to 1.00mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.33mg/kg (Cohort 6)
n=6 Participants
Participants received luspatercept titrated up to 1.33mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Concentration (Cmax) of Luspatercept
|
9.66 ug/mL
Geometric Coefficient of Variation 7.52
|
5.73 ug/mL
Geometric Coefficient of Variation 26.93
|
0.64 ug/mL
Geometric Coefficient of Variation 34.88
|
0.96 ug/mL
Geometric Coefficient of Variation 92.99
|
2.33 ug/mL
Geometric Coefficient of Variation 27.16
|
3.76 ug/mL
Geometric Coefficient of Variation 42.29
|
4.35 ug/mL
Geometric Coefficient of Variation 12.87
|
7.46 ug/mL
Geometric Coefficient of Variation 14.55
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: Predose, Cycle 1 Days 8, 11, 15 and Cycle 2 Day 1: Postdose (each cycle length = 21 days)Population: All participants who received at least one dose of luspatercept and had sufficient pharmacokinetic samples collected and assayed.
Blood samples were collected at specified intervals for the determination of AUC0-21. AUC0-21 was defined as the area under the concentration-time curve of luspatercept from time zero to Study Day 21. AUC0-21 was based on non-compartmental analysis and a mean AUC0-21 value was presented.
Outcome measures
| Measure |
Luspatercept 1.75mg/kg (Cohort 7)
n=3 Participants
Participants received luspatercept titrated up to 1.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Expansion Cohort
n=87 Participants
Participants received an initial dose of luspatercept 1.0mg/kg SC on Day 1 of the Cycle 1 (Cycle length = 21 days). For each subsequent cycle (up to 5 cycles), the dose was titrated via Fibonacci scheme up to a maximum dose of 1.75mg/kg based on the safety review team (SRT) recommendations.
|
Luspatercept 0.125mg/kg (Cohort 1)
n=3 Participants
Participants received luspatercept 0.125mg/kg as a subcutaneous (SC) injection every 3 weeks (Q3W) on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.25mg/kg (Cohort 2)
n=3 Participants
Participants received luspatercept titrated up to 0.25mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.50mg/kg (Cohort 3)
n=2 Participants
Participants received luspatercept titrated up to 0.50mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.75mg/kg (Cohort 4)
n=6 Participants
Participants received luspatercept titrated up to 0.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.00mg/kg (Cohort 5)
n=3 Participants
Participants received luspatercept titrated up to 1.00mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.33mg/kg (Cohort 6)
n=6 Participants
Participants received luspatercept titrated up to 1.33mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve of Luspatercept From Time 0 to Day 21 (AUC0-21)
|
137.56 day*ug/m
Geometric Coefficient of Variation 1.13
|
80.02 day*ug/m
Geometric Coefficient of Variation 27.77
|
9.29 day*ug/m
Geometric Coefficient of Variation 32.16
|
12.56 day*ug/m
Geometric Coefficient of Variation 94.99
|
36.90 day*ug/m
Geometric Coefficient of Variation 4.19
|
51.82 day*ug/m
Geometric Coefficient of Variation 35.93
|
62.46 day*ug/m
Geometric Coefficient of Variation 25.20
|
112.56 day*ug/m
Geometric Coefficient of Variation 17.00
|
SECONDARY outcome
Timeframe: Baseline (prior to first dose of luspatercept) and Day 113Population: No data were collected for the percent change from baseline to day 113 in concentration of serum iron.
Blood samples were to be collected at pre-specified time intervals to determine serum iron concentration. Baseline was prespecified to be the last measurement prior to the first dose of study drug.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (prior to first dose of luspatercept) and Day 113Population: All enrolled participants who received at least one dose of luspatercept and had data available for TIBC.
Blood samples were collected at pre-specified time intervals to determine TIBC. The percentage change from baseline in TIBC was reported.
Outcome measures
| Measure |
Luspatercept 1.75mg/kg (Cohort 7)
n=2 Participants
Participants received luspatercept titrated up to 1.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Expansion Cohort
n=86 Participants
Participants received an initial dose of luspatercept 1.0mg/kg SC on Day 1 of the Cycle 1 (Cycle length = 21 days). For each subsequent cycle (up to 5 cycles), the dose was titrated via Fibonacci scheme up to a maximum dose of 1.75mg/kg based on the safety review team (SRT) recommendations.
|
Luspatercept 0.125mg/kg (Cohort 1)
n=3 Participants
Participants received luspatercept 0.125mg/kg as a subcutaneous (SC) injection every 3 weeks (Q3W) on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.25mg/kg (Cohort 2)
n=3 Participants
Participants received luspatercept titrated up to 0.25mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.50mg/kg (Cohort 3)
n=3 Participants
Participants received luspatercept titrated up to 0.50mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.75mg/kg (Cohort 4)
n=5 Participants
Participants received luspatercept titrated up to 0.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.00mg/kg (Cohort 5)
n=3 Participants
Participants received luspatercept titrated up to 1.00mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.33mg/kg (Cohort 6)
n=5 Participants
Participants received luspatercept titrated up to 1.33mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline to Day 113 in Total Iron Binding Capacity (TIBC)
|
-4.16 Percent change
Standard Deviation 2.435
|
-2.40 Percent change
Standard Deviation 9.916
|
-1.49 Percent change
Standard Deviation 8.940
|
1.61 Percent change
Standard Deviation 1.392
|
-6.70 Percent change
Standard Deviation 6.050
|
10.91 Percent change
Standard Deviation 11.806
|
7.46 Percent change
Standard Deviation 11.727
|
-12.27 Percent change
Standard Deviation 22.144
|
SECONDARY outcome
Timeframe: Baseline (prior to first dose of luspatercept) and Day 113Population: No data were collected for the percent change from baseline to day 113 in concentration of transferrin.
Blood samples were to be collected at pre-specified time intervals to determine concentration of transferrin. Baseline was prespecified to be the last measurement prior to the first dose of study drug.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (prior to first dose of luspatercept) and Day 113Population: All enrolled participants who received at least one dose of luspatercept and had data available for soluble transferrin receptor.
Blood samples were collected at pre-specified time intervals to determine soluble transferrin receptor concentration. The percentage change from baseline in concentration of soluble transferrin receptor was reported.
Outcome measures
| Measure |
Luspatercept 1.75mg/kg (Cohort 7)
n=2 Participants
Participants received luspatercept titrated up to 1.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Expansion Cohort
n=77 Participants
Participants received an initial dose of luspatercept 1.0mg/kg SC on Day 1 of the Cycle 1 (Cycle length = 21 days). For each subsequent cycle (up to 5 cycles), the dose was titrated via Fibonacci scheme up to a maximum dose of 1.75mg/kg based on the safety review team (SRT) recommendations.
|
Luspatercept 0.125mg/kg (Cohort 1)
n=3 Participants
Participants received luspatercept 0.125mg/kg as a subcutaneous (SC) injection every 3 weeks (Q3W) on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.25mg/kg (Cohort 2)
n=2 Participants
Participants received luspatercept titrated up to 0.25mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.50mg/kg (Cohort 3)
n=2 Participants
Participants received luspatercept titrated up to 0.50mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.75mg/kg (Cohort 4)
n=5 Participants
Participants received luspatercept titrated up to 0.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.00mg/kg (Cohort 5)
Participants received luspatercept titrated up to 1.00mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.33mg/kg (Cohort 6)
n=5 Participants
Participants received luspatercept titrated up to 1.33mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline to Day 113 in Concentration of Soluble Transferrin Receptor
|
19.25 Percent change
Standard Deviation 7.793
|
35.35 Percent change
Standard Deviation 44.228
|
60.88 Percent change
Standard Deviation 76.427
|
-31.46 Percent change
Standard Deviation 5.135
|
-4.62 Percent change
Standard Deviation 6.527
|
36.35 Percent change
Standard Deviation 21.718
|
—
|
-17.11 Percent change
Standard Deviation 32.861
|
SECONDARY outcome
Timeframe: Baseline (prior to first dose of luspatercept) and Day 113Population: All enrolled participants who received at least one dose of luspatercept and had data available for serum ferritin.
Blood samples were collected at pre-specified time intervals to determine serum ferritin concentration. The percentage change from baseline in concentration of serum ferritin was reported.
Outcome measures
| Measure |
Luspatercept 1.75mg/kg (Cohort 7)
n=2 Participants
Participants received luspatercept titrated up to 1.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Expansion Cohort
n=87 Participants
Participants received an initial dose of luspatercept 1.0mg/kg SC on Day 1 of the Cycle 1 (Cycle length = 21 days). For each subsequent cycle (up to 5 cycles), the dose was titrated via Fibonacci scheme up to a maximum dose of 1.75mg/kg based on the safety review team (SRT) recommendations.
|
Luspatercept 0.125mg/kg (Cohort 1)
n=3 Participants
Participants received luspatercept 0.125mg/kg as a subcutaneous (SC) injection every 3 weeks (Q3W) on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.25mg/kg (Cohort 2)
n=3 Participants
Participants received luspatercept titrated up to 0.25mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.50mg/kg (Cohort 3)
n=3 Participants
Participants received luspatercept titrated up to 0.50mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.75mg/kg (Cohort 4)
n=5 Participants
Participants received luspatercept titrated up to 0.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.00mg/kg (Cohort 5)
n=3 Participants
Participants received luspatercept titrated up to 1.00mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.33mg/kg (Cohort 6)
n=5 Participants
Participants received luspatercept titrated up to 1.33mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline to Day 113 in Concentration of Serum Ferritin
|
-16.07 Percent change
Standard Deviation 27.172
|
-1.51 Percent change
Standard Deviation 46.269
|
-19.55 Percent change
Standard Deviation 32.845
|
58.63 Percent change
Standard Deviation 24.342
|
74.31 Percent change
Standard Deviation 160.308
|
1.16 Percent change
Standard Deviation 23.487
|
19.38 Percent change
Standard Deviation 25.666
|
8.56 Percent change
Standard Deviation 41.532
|
SECONDARY outcome
Timeframe: Baseline (prior to first dose of luspatercept) and Day 113Population: No data were collected for the percent change from baseline to day 113 in concentration of NTBI.
Blood samples were to be collected at pre-specified time intervals to determine concentration of NTBI. Baseline was prespecified to be the last measurement prior to the first dose of study drug.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (prior to first dose of luspatercept) and Day 113Population: All enrolled participants who received at least one dose of luspatercept and had data available for serum hepcidin.
Blood samples were collected at pre-specified time intervals to determine soluble hepcidin concentration. The percentage change from baseline in concentration of soluble hepcidin was reported.
Outcome measures
| Measure |
Luspatercept 1.75mg/kg (Cohort 7)
n=1 Participants
Participants received luspatercept titrated up to 1.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Expansion Cohort
n=64 Participants
Participants received an initial dose of luspatercept 1.0mg/kg SC on Day 1 of the Cycle 1 (Cycle length = 21 days). For each subsequent cycle (up to 5 cycles), the dose was titrated via Fibonacci scheme up to a maximum dose of 1.75mg/kg based on the safety review team (SRT) recommendations.
|
Luspatercept 0.125mg/kg (Cohort 1)
n=3 Participants
Participants received luspatercept 0.125mg/kg as a subcutaneous (SC) injection every 3 weeks (Q3W) on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.25mg/kg (Cohort 2)
n=3 Participants
Participants received luspatercept titrated up to 0.25mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.50mg/kg (Cohort 3)
n=3 Participants
Participants received luspatercept titrated up to 0.50mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.75mg/kg (Cohort 4)
n=4 Participants
Participants received luspatercept titrated up to 0.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.00mg/kg (Cohort 5)
n=3 Participants
Participants received luspatercept titrated up to 1.00mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.33mg/kg (Cohort 6)
n=5 Participants
Participants received luspatercept titrated up to 1.33mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline to Day 113 in Concentration of Serum Hepcidin
|
-64.51 Percent change
Standard Deviation NA
NA = SD could not be calculated due to low number of participants with hepcidin values
|
30.15 Percent change
Standard Deviation 143.118
|
-42.40 Percent change
Standard Deviation 5.907
|
6.56 Percent change
Standard Deviation 35.740
|
-14.55 Percent change
Standard Deviation 39.855
|
-15.62 Percent change
Standard Deviation 20.814
|
-5.54 Percent change
Standard Deviation 49.144
|
65.41 Percent change
Standard Deviation 179.249
|
SECONDARY outcome
Timeframe: Baseline (prior to first dose of luspatercept) and Day 113Population: All participants who received at least one dose of luspatercept and had data available for serum erythropoietin.
Blood samples were collected at pre-specified time intervals to determine serum erythropoietin concentration. The percentage change from baseline in concentration of serum erythropoietin was reported.
Outcome measures
| Measure |
Luspatercept 1.75mg/kg (Cohort 7)
n=2 Participants
Participants received luspatercept titrated up to 1.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Expansion Cohort
n=84 Participants
Participants received an initial dose of luspatercept 1.0mg/kg SC on Day 1 of the Cycle 1 (Cycle length = 21 days). For each subsequent cycle (up to 5 cycles), the dose was titrated via Fibonacci scheme up to a maximum dose of 1.75mg/kg based on the safety review team (SRT) recommendations.
|
Luspatercept 0.125mg/kg (Cohort 1)
n=3 Participants
Participants received luspatercept 0.125mg/kg as a subcutaneous (SC) injection every 3 weeks (Q3W) on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.25mg/kg (Cohort 2)
n=3 Participants
Participants received luspatercept titrated up to 0.25mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.50mg/kg (Cohort 3)
n=2 Participants
Participants received luspatercept titrated up to 0.50mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.75mg/kg (Cohort 4)
n=5 Participants
Participants received luspatercept titrated up to 0.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.00mg/kg (Cohort 5)
n=2 Participants
Participants received luspatercept titrated up to 1.00mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.33mg/kg (Cohort 6)
n=5 Participants
Participants received luspatercept titrated up to 1.33mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline to Day 113 in Concentration of Serum Erythropoietin
|
29.07 Percent change
Standard Deviation 80.426
|
238.85 Percent change
Standard Deviation 974.226
|
144.48 Percent change
Standard Deviation 232.336
|
110.51 Percent change
Standard Deviation 85.751
|
122.85 Percent change
Standard Deviation 163.500
|
1.81 Percent change
Standard Deviation 48.208
|
749.10 Percent change
Standard Deviation 902.000
|
146.49 Percent change
Standard Deviation 160.087
|
SECONDARY outcome
Timeframe: Baseline (prior to first dose of luspatercept) and Day 113Population: All enrolled participants who received at least one dose of luspatercept and had data available for reticulocyte count.
Blood samples were collected at pre-specified time intervals to determine reticulocyte count. The percentage change from baseline in mean reticulocyte count was reported.
Outcome measures
| Measure |
Luspatercept 1.75mg/kg (Cohort 7)
n=2 Participants
Participants received luspatercept titrated up to 1.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Expansion Cohort
n=74 Participants
Participants received an initial dose of luspatercept 1.0mg/kg SC on Day 1 of the Cycle 1 (Cycle length = 21 days). For each subsequent cycle (up to 5 cycles), the dose was titrated via Fibonacci scheme up to a maximum dose of 1.75mg/kg based on the safety review team (SRT) recommendations.
|
Luspatercept 0.125mg/kg (Cohort 1)
n=3 Participants
Participants received luspatercept 0.125mg/kg as a subcutaneous (SC) injection every 3 weeks (Q3W) on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.25mg/kg (Cohort 2)
n=1 Participants
Participants received luspatercept titrated up to 0.25mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.50mg/kg (Cohort 3)
n=2 Participants
Participants received luspatercept titrated up to 0.50mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.75mg/kg (Cohort 4)
n=5 Participants
Participants received luspatercept titrated up to 0.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.00mg/kg (Cohort 5)
n=3 Participants
Participants received luspatercept titrated up to 1.00mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.33mg/kg (Cohort 6)
n=3 Participants
Participants received luspatercept titrated up to 1.33mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline to Day 113 in Reticulocyte Count
|
84.06 Percent change
Standard Deviation 108.298
|
41.37 Percent change
Standard Deviation 73.445
|
110.82 Percent change
Standard Deviation 127.489
|
8.10 Percent change
Standard Deviation NA
NA=SD could not be calculated due to insufficient number of participants in the study.
|
79.77 Percent change
Standard Deviation 45.816
|
28.29 Percent change
Standard Deviation 28.434
|
76.16 Percent change
Standard Deviation 54.003
|
0.45 Percent change
Standard Deviation 19.770
|
SECONDARY outcome
Timeframe: Baseline (prior to first dose of luspatercept) and Day 113Population: All enrolled participants who received at least one dose of luspatercept and had data available for direct bilirubin.
Blood samples were collected at pre-specified time intervals to determine serum direct bilirubin concentration. The percentage change from baseline in mean concentration direct bilirubin was reported.
Outcome measures
| Measure |
Luspatercept 1.75mg/kg (Cohort 7)
n=1 Participants
Participants received luspatercept titrated up to 1.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Expansion Cohort
n=64 Participants
Participants received an initial dose of luspatercept 1.0mg/kg SC on Day 1 of the Cycle 1 (Cycle length = 21 days). For each subsequent cycle (up to 5 cycles), the dose was titrated via Fibonacci scheme up to a maximum dose of 1.75mg/kg based on the safety review team (SRT) recommendations.
|
Luspatercept 0.125mg/kg (Cohort 1)
n=3 Participants
Participants received luspatercept 0.125mg/kg as a subcutaneous (SC) injection every 3 weeks (Q3W) on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.25mg/kg (Cohort 2)
n=2 Participants
Participants received luspatercept titrated up to 0.25mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.50mg/kg (Cohort 3)
n=1 Participants
Participants received luspatercept titrated up to 0.50mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.75mg/kg (Cohort 4)
n=4 Participants
Participants received luspatercept titrated up to 0.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.00mg/kg (Cohort 5)
n=1 Participants
Participants received luspatercept titrated up to 1.00mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.33mg/kg (Cohort 6)
n=3 Participants
Participants received luspatercept titrated up to 1.33mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline to Day 113 in Direct Bilirubin Level
|
6.78 Percent change
Standard Deviation NA
NA = SD could not be calculated due to low number of participants with direct bilirubin values
|
-0.50 Percent change
Standard Deviation 27.541
|
-18.45 Percent change
Standard Deviation 6.569
|
12.38 Percent change
Standard Deviation 38.465
|
2.33 Percent change
Standard Deviation NA
NA = SD could not be calculated due to low number of participants with direct bilirubin values
|
7.22 Percent change
Standard Deviation 20.592
|
-5.00 Percent change
Standard Deviation NA
NA = SD could not be calculated due to low number of participants with direct bilirubin values
|
-7.41 Percent change
Standard Deviation 12.830
|
SECONDARY outcome
Timeframe: Baseline (prior to first dose of luspatercept) and Day 113Population: All enrolled participants who received at least one dose of luspatercept and had data available for total bilirubin.
Blood samples were collected at pre-specified time intervals to determine total bilirubin concentration. The percentage change from baseline in mean concentration total bilirubin was reported.
Outcome measures
| Measure |
Luspatercept 1.75mg/kg (Cohort 7)
n=2 Participants
Participants received luspatercept titrated up to 1.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Expansion Cohort
n=85 Participants
Participants received an initial dose of luspatercept 1.0mg/kg SC on Day 1 of the Cycle 1 (Cycle length = 21 days). For each subsequent cycle (up to 5 cycles), the dose was titrated via Fibonacci scheme up to a maximum dose of 1.75mg/kg based on the safety review team (SRT) recommendations.
|
Luspatercept 0.125mg/kg (Cohort 1)
n=3 Participants
Participants received luspatercept 0.125mg/kg as a subcutaneous (SC) injection every 3 weeks (Q3W) on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.25mg/kg (Cohort 2)
n=3 Participants
Participants received luspatercept titrated up to 0.25mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.50mg/kg (Cohort 3)
n=3 Participants
Participants received luspatercept titrated up to 0.50mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.75mg/kg (Cohort 4)
n=5 Participants
Participants received luspatercept titrated up to 0.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.00mg/kg (Cohort 5)
n=3 Participants
Participants received luspatercept titrated up to 1.00mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.33mg/kg (Cohort 6)
n=5 Participants
Participants received luspatercept titrated up to 1.33mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline to Day 113 in Total Bilirubin Level
|
10.68 Percent change
Standard Deviation 20.258
|
13.26 Percent change
Standard Deviation 37.239
|
-25.41 Percent change
Standard Deviation 5.596
|
4.32 Percent change
Standard Deviation 26.094
|
47.43 Percent change
Standard Deviation 51.076
|
4.02 Percent change
Standard Deviation 10.439
|
-25.08 Percent change
Standard Deviation 17.240
|
-25.84 Percent change
Standard Deviation 19.893
|
SECONDARY outcome
Timeframe: Baseline (prior to first dose of luspatercept) and Day 113Population: All enrolled participants who received at least one dose of luspatercept and had data available for lactate dehydrogenase.
Blood samples were collected at pre-specified time intervals to determine serum lactate dehydrogenase level. The percentage change from baseline in mean concentration lactate dehydrogenase level was reported.
Outcome measures
| Measure |
Luspatercept 1.75mg/kg (Cohort 7)
n=2 Participants
Participants received luspatercept titrated up to 1.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Expansion Cohort
n=85 Participants
Participants received an initial dose of luspatercept 1.0mg/kg SC on Day 1 of the Cycle 1 (Cycle length = 21 days). For each subsequent cycle (up to 5 cycles), the dose was titrated via Fibonacci scheme up to a maximum dose of 1.75mg/kg based on the safety review team (SRT) recommendations.
|
Luspatercept 0.125mg/kg (Cohort 1)
n=3 Participants
Participants received luspatercept 0.125mg/kg as a subcutaneous (SC) injection every 3 weeks (Q3W) on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.25mg/kg (Cohort 2)
n=3 Participants
Participants received luspatercept titrated up to 0.25mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.50mg/kg (Cohort 3)
n=3 Participants
Participants received luspatercept titrated up to 0.50mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.75mg/kg (Cohort 4)
n=5 Participants
Participants received luspatercept titrated up to 0.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.00mg/kg (Cohort 5)
n=3 Participants
Participants received luspatercept titrated up to 1.00mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.33mg/kg (Cohort 6)
n=5 Participants
Participants received luspatercept titrated up to 1.33mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline to Day 113 in Lactate Dehydrogenase Level
|
-11.91 Percent change
Standard Deviation 35.318
|
20.58 Percent change
Standard Deviation 46.589
|
13.09 Percent change
Standard Deviation 28.850
|
-10.28 Percent change
Standard Deviation 6.589
|
0.03 Percent change
Standard Deviation 32.694
|
2.76 Percent change
Standard Deviation 7.848
|
-15.20 Percent change
Standard Deviation 25.355
|
-2.52 Percent change
Standard Deviation 18.669
|
SECONDARY outcome
Timeframe: Baseline (prior to first dose of luspatercept) and Day 113Population: No data were collected for the percent change from baseline to day 113 in concentration of nRBC.
Blood samples were to be collected at pre-specified time intervals to determine concentration of nRBC. Baseline was prespecified to be the last measurement prior to the first dose of study drug.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (prior to first dose of luspatercept) and Day 113Population: All enrolled participants who received at least one dose of luspatercept and had data available for BSAP.
Blood samples were collected at pre-specified time intervals to determine serum BSAP concentration. The percentage change from baseline in concentration BSAP was reported.
Outcome measures
| Measure |
Luspatercept 1.75mg/kg (Cohort 7)
n=1 Participants
Participants received luspatercept titrated up to 1.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Expansion Cohort
n=23 Participants
Participants received an initial dose of luspatercept 1.0mg/kg SC on Day 1 of the Cycle 1 (Cycle length = 21 days). For each subsequent cycle (up to 5 cycles), the dose was titrated via Fibonacci scheme up to a maximum dose of 1.75mg/kg based on the safety review team (SRT) recommendations.
|
Luspatercept 0.125mg/kg (Cohort 1)
n=2 Participants
Participants received luspatercept 0.125mg/kg as a subcutaneous (SC) injection every 3 weeks (Q3W) on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.25mg/kg (Cohort 2)
n=3 Participants
Participants received luspatercept titrated up to 0.25mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.50mg/kg (Cohort 3)
n=3 Participants
Participants received luspatercept titrated up to 0.50mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.75mg/kg (Cohort 4)
n=5 Participants
Participants received luspatercept titrated up to 0.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.00mg/kg (Cohort 5)
n=3 Participants
Participants received luspatercept titrated up to 1.00mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.33mg/kg (Cohort 6)
n=5 Participants
Participants received luspatercept titrated up to 1.33mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline to Day 113 in Concentration of Serum Bone-Specific Alkaline Phosphatase (BSAP)
|
15.27 Percent change
Standard Deviation NA
NA = SD could not be calculated due to low number of participants with BSAP values
|
8.31 Percent change
Standard Deviation 23.800
|
-6.41 Percent change
Standard Deviation 3.698
|
-36.70 Percent change
Standard Deviation 9.430
|
-24.60 Percent change
Standard Deviation 16.413
|
47.48 Percent change
Standard Deviation 42.431
|
14.15 Percent change
Standard Deviation 13.191
|
-6.43 Percent change
Standard Deviation 25.559
|
SECONDARY outcome
Timeframe: Baseline (prior to first dose of luspatercept) and Day 113Population: All enrolled participants who received at least one dose of luspatercept and had data available for CTX.
Blood samples were collected at pre-specified time intervals to determine serum CTX. The percentage change from baseline in concentration of CTX was reported.
Outcome measures
| Measure |
Luspatercept 1.75mg/kg (Cohort 7)
n=1 Participants
Participants received luspatercept titrated up to 1.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Expansion Cohort
n=24 Participants
Participants received an initial dose of luspatercept 1.0mg/kg SC on Day 1 of the Cycle 1 (Cycle length = 21 days). For each subsequent cycle (up to 5 cycles), the dose was titrated via Fibonacci scheme up to a maximum dose of 1.75mg/kg based on the safety review team (SRT) recommendations.
|
Luspatercept 0.125mg/kg (Cohort 1)
n=1 Participants
Participants received luspatercept 0.125mg/kg as a subcutaneous (SC) injection every 3 weeks (Q3W) on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.25mg/kg (Cohort 2)
Participants received luspatercept titrated up to 0.25mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.50mg/kg (Cohort 3)
n=1 Participants
Participants received luspatercept titrated up to 0.50mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.75mg/kg (Cohort 4)
n=5 Participants
Participants received luspatercept titrated up to 0.75mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.00mg/kg (Cohort 5)
n=3 Participants
Participants received luspatercept titrated up to 1.00mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.33mg/kg (Cohort 6)
n=4 Participants
Participants received luspatercept titrated up to 1.33mg/kg via Fibonacci scheme, SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline to Day 113 in Concentration of Serum Cross-Linked C-Telopeptide of Type I Collagen (CTX)
|
-70.97 Percent change
Standard Deviation NA
NA = SD could not be calculated due to low number of participants with CTX values
|
22.66 Percent change
Standard Deviation 51.177
|
-4.42 Percent change
Standard Deviation NA
NA = SD could not be calculated due to low number of participants with CTX values
|
—
|
16.26 Percent change
Standard Deviation NA
NA = SD could not be calculated due to low number of participants with CTX values
|
26.37 Percent change
Standard Deviation 24.669
|
15.94 Percent change
Standard Deviation 35.018
|
13.04 Percent change
Standard Deviation 62.513
|
Adverse Events
Luspatercept 0.125 mg/kg (Cohort 1)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Luspatercept 0.25 mg/kg (Cohort 2)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Luspatercept 0.50 mg/kg (Cohort 3)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Luspatercept 0.75 mg/kg (Cohort 4)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Luspatercept 1.0 mg/kg (Cohort 5)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Luspatercept 1.33 mg/kg (Cohort 6)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Luspatercept 1.75 mg/kg (Cohort 7)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Expansion Cohort
Serious events: 14 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Luspatercept 0.125 mg/kg (Cohort 1)
n=3 participants at risk
Participants received luspatercept 0.125mg/kg as a subcutaneous (SC) injection every 3 weeks (Q3W) on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days)
|
Luspatercept 0.25 mg/kg (Cohort 2)
n=3 participants at risk
Participants received luspatercept titrated up to 0.25mg/kg SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.50 mg/kg (Cohort 3)
n=3 participants at risk
Participants received luspatercept titrated up to 0.50mg/kg SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.75 mg/kg (Cohort 4)
n=6 participants at risk
Participants received luspatercept titrated up to 0.75mg/kg SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.0 mg/kg (Cohort 5)
n=3 participants at risk
Participants received luspatercept titrated up to 1mg/kg SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.33 mg/kg (Cohort 6)
n=6 participants at risk
Participants received luspatercept titrated up to 1.33mg/kg SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.75 mg/kg (Cohort 7)
n=3 participants at risk
Participants received luspatercept titrated up to 1.75mg/kg SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Expansion Cohort
n=89 participants at risk
Participants received an initial dose of luspatercept 1mg/kg SC on Day 1 of the Cycle 1 (Cycle length = 21 days). For each subsequent cycle (up to 5 cycles), the dose was titrated up to a maximum dose of 1.75mg/kg based on the safety review team (SRT) recommendations.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.1%
1/89 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.1%
1/89 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.1%
1/89 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.1%
1/89 • Number of events 2 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Haematoma infection
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.1%
1/89 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.1%
1/89 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.1%
1/89 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.1%
1/89 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.1%
1/89 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.1%
1/89 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.1%
1/89 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.1%
1/89 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transformation to acute myeloid leukaemia
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.1%
1/89 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.1%
1/89 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.1%
1/89 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Vascular disorders
Temporal arteritis
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.1%
1/89 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
Other adverse events
| Measure |
Luspatercept 0.125 mg/kg (Cohort 1)
n=3 participants at risk
Participants received luspatercept 0.125mg/kg as a subcutaneous (SC) injection every 3 weeks (Q3W) on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days)
|
Luspatercept 0.25 mg/kg (Cohort 2)
n=3 participants at risk
Participants received luspatercept titrated up to 0.25mg/kg SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.50 mg/kg (Cohort 3)
n=3 participants at risk
Participants received luspatercept titrated up to 0.50mg/kg SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 0.75 mg/kg (Cohort 4)
n=6 participants at risk
Participants received luspatercept titrated up to 0.75mg/kg SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.0 mg/kg (Cohort 5)
n=3 participants at risk
Participants received luspatercept titrated up to 1mg/kg SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.33 mg/kg (Cohort 6)
n=6 participants at risk
Participants received luspatercept titrated up to 1.33mg/kg SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Luspatercept 1.75 mg/kg (Cohort 7)
n=3 participants at risk
Participants received luspatercept titrated up to 1.75mg/kg SC injection Q3W on Day 1 of each cycle for up to 5 cycles (each cycle length = 21 days).
|
Expansion Cohort
n=89 participants at risk
Participants received an initial dose of luspatercept 1mg/kg SC on Day 1 of the Cycle 1 (Cycle length = 21 days). For each subsequent cycle (up to 5 cycles), the dose was titrated up to a maximum dose of 1.75mg/kg based on the safety review team (SRT) recommendations.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
3.4%
3/89 • Number of events 5 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Red blood cell abnormality
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.1%
1/89 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
2.2%
2/89 • Number of events 2 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
4.5%
4/89 • Number of events 4 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.1%
1/89 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 4 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
5.6%
5/89 • Number of events 5 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 2 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
2.2%
2/89 • Number of events 2 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 2 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.1%
1/89 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
3.4%
3/89 • Number of events 3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
50.0%
3/6 • Number of events 4 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
12.4%
11/89 • Number of events 12 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
General disorders
Injection site erythema
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
2.2%
2/89 • Number of events 2 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
General disorders
Injection site pain
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
General disorders
Injection site pruritus
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.1%
1/89 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
General disorders
Injection site rash
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
General disorders
Injection site swelling
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.1%
1/89 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
6.7%
6/89 • Number of events 7 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
6.7%
6/89 • Number of events 7 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
2.2%
2/89 • Number of events 2 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
12.4%
11/89 • Number of events 12 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
3.4%
3/89 • Number of events 7 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 2 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
2.2%
2/89 • Number of events 2 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.1%
1/89 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
5.6%
5/89 • Number of events 6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 4 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
5.6%
5/89 • Number of events 9 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 2 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.1%
1/89 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.1%
1/89 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
6.7%
6/89 • Number of events 7 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.1%
1/89 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelofibrosis
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transformation to acute myeloid leukaemia
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 2 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
4.5%
4/89 • Number of events 7 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
10.1%
9/89 • Number of events 12 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Migraine
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.1%
1/89 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
3.4%
3/89 • Number of events 4 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.1%
1/89 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
3.4%
3/89 • Number of events 3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.1%
1/89 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 2 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
2.2%
2/89 • Number of events 5 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
4.5%
4/89 • Number of events 4 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/89 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.1%
1/89 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
21.3%
19/89 • Number of events 25 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.1%
1/89 • Number of events 1 • Up to approximately 75 weeks
All-cause mortality was reported on all enrolled participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The publication or disclosure of study results will be permitted as per the agreement between the sponsor and the investigator(s).
- Publication restrictions are in place
Restriction type: OTHER