Trial Outcomes & Findings for Extension Study to Evaluate Long-Term Effects of Luspatercept in Patients With Myelodysplastic Syndromes (MDS) (A536-05/MK-6143-003) (NCT NCT02268383)
NCT ID: NCT02268383
Last Updated: 2024-07-29
Results Overview
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 was reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
75 participants
Primary outcome timeframe
Up to approximately 5 years
Results posted on
2024-07-29
Participant Flow
This extension study enrolled participants from base study MK-6143-001 (NCT01749514). Participants were referred as 'Direct Roll Over' participants (n=67; enrolled within \~28 days after last dose of luspatercept and did not complete post treatment follow up (PTFU) or end of study (EOS) visit of base study) or 'Treatment Interrupted' participants (n=8; completed EOS visit for base study). Per protocol, a total of 75 participants were pooled together in the extension study.
Participant milestones
| Measure |
Luspatercept Extension Population
Participants received luspatercept dose of either 0.5, 0.75, 1.0, 1.33, or 1.75 mg/kg determined via Fibonacci scheme on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years) as a subcutaneous (SC) injection. Direct Roll Over participants received the highest tolerated dose of luspatercept that was assigned in the base study. Treatment Interrupted participants received an initial dose of luspatercept 1mg/kg on Day 1 of Cycle 1 (cycle length = 21 days) and the subsequent doses were titrated up to 1.75mg/kg Q3W via Fibonacci scheme, on Day 1 of each cycle for up to 87 cycles (for up to approximately 5 years).
|
|---|---|
|
Overall Study
STARTED
|
75
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
61
|
Reasons for withdrawal
| Measure |
Luspatercept Extension Population
Participants received luspatercept dose of either 0.5, 0.75, 1.0, 1.33, or 1.75 mg/kg determined via Fibonacci scheme on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years) as a subcutaneous (SC) injection. Direct Roll Over participants received the highest tolerated dose of luspatercept that was assigned in the base study. Treatment Interrupted participants received an initial dose of luspatercept 1mg/kg on Day 1 of Cycle 1 (cycle length = 21 days) and the subsequent doses were titrated up to 1.75mg/kg Q3W via Fibonacci scheme, on Day 1 of each cycle for up to 87 cycles (for up to approximately 5 years).
|
|---|---|
|
Overall Study
Death
|
12
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
9
|
|
Overall Study
Presence of ≥1% blasts in peripheral blood
|
1
|
|
Overall Study
Protocol deviation
|
3
|
|
Overall Study
Sponsor decision
|
22
|
|
Overall Study
Not reported
|
12
|
Baseline Characteristics
All enrolled participants with baseline hemoglobin level data available. Data were not collected from 2 participants at baseline.
Baseline characteristics by cohort
| Measure |
Luspatercept Extension Population
n=75 Participants
Participants received luspatercept dose of either 0.5, 0.75, 1.0, 1.33, or 1.75 mg/kg determined via Fibonacci scheme on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years) as a subcutaneous (SC) injection. Direct Roll Over participants received the highest tolerated dose of luspatercept that was assigned in the base study. Treatment Interrupted participants received an initial dose of luspatercept 1mg/kg on Day 1 of Cycle 1 (cycle length = 21 days) and the subsequent doses were titrated up to 1.75mg/kg Q3W via Fibonacci scheme, on Day 1 of each cycle for up to 87 cycles (for up to approximately 5 years).
|
|---|---|
|
Age, Continuous
|
70.9 Years
STANDARD_DEVIATION 11.0 • n=75 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=75 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=75 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=75 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=75 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=75 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=75 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=75 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=75 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=75 Participants
|
|
Race (NIH/OMB)
White
|
75 Participants
n=75 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=75 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=75 Participants
|
|
Transfusion Status
HTB
|
25 Participants
n=75 Participants
|
|
Transfusion Status
LTB
|
50 Participants
n=75 Participants
|
|
Hemoglobin level
|
8.74 grams/dl
STANDARD_DEVIATION 1.01 • n=73 Participants • All enrolled participants with baseline hemoglobin level data available. Data were not collected from 2 participants at baseline.
|
PRIMARY outcome
Timeframe: Up to approximately 5 yearsPopulation: 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 was reported.
Outcome measures
| Measure |
Luspatercept Extension Population
n=75 Participants
Participants received luspatercept dose of either 0.5, 0.75, 1.0, 1.33, or 1.75 mg/kg determined via Fibonacci scheme on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years) as a subcutaneous (SC) injection. Direct Roll Over participants received the highest tolerated dose of luspatercept that was assigned in the base study. Treatment Interrupted participants received an initial dose of luspatercept 1mg/kg on Day 1 of Cycle 1 (cycle length = 21 days) and the subsequent doses were titrated up to 1.75mg/kg Q3W via Fibonacci scheme, on Day 1 of each cycle for up to 87 cycles (for up to approximately 5 years).
|
|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE)
|
75 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 5 yearsPopulation: 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 luspatercept due to an AE was reported.
Outcome measures
| Measure |
Luspatercept Extension Population
n=75 Participants
Participants received luspatercept dose of either 0.5, 0.75, 1.0, 1.33, or 1.75 mg/kg determined via Fibonacci scheme on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years) as a subcutaneous (SC) injection. Direct Roll Over participants received the highest tolerated dose of luspatercept that was assigned in the base study. Treatment Interrupted participants received an initial dose of luspatercept 1mg/kg on Day 1 of Cycle 1 (cycle length = 21 days) and the subsequent doses were titrated up to 1.75mg/kg Q3W via Fibonacci scheme, on Day 1 of each cycle for up to 87 cycles (for up to approximately 5 years).
|
|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to an AE
|
23 Participants
|
SECONDARY outcome
Timeframe: Any consecutive 8 weeks during the study (up to approximately 5 years)Population: All enrolled participants who received at least one dose of luspatercept and were mHI-E evaluable.
The mHI-E was defined as a mean hemoglobin (Hgb) increase ≥1.5 g/dL over an 8-week period as compared to baseline, not influenced by red blood cell (RBC) transfusion in low transfusion burden (LTB) participants and a decrease of ≥4 units or ≥50% of units of RBCs transfused over a period of 8 weeks, relative to the number of units of RBCs transfused in the 8 weeks immediately prior to baseline in high transfusion burden (HTB) participants. LTB participants were those who received \<4 units of RBCs within 8 weeks prior to baseline. HTB participants were those who required a transfusion of ≥4 units of RBCs in the 8 weeks prior to baseline. Rolling 8 weeks was defined as any consecutive 8 weeks during the study.
Outcome measures
| Measure |
Luspatercept Extension Population
n=75 Participants
Participants received luspatercept dose of either 0.5, 0.75, 1.0, 1.33, or 1.75 mg/kg determined via Fibonacci scheme on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years) as a subcutaneous (SC) injection. Direct Roll Over participants received the highest tolerated dose of luspatercept that was assigned in the base study. Treatment Interrupted participants received an initial dose of luspatercept 1mg/kg on Day 1 of Cycle 1 (cycle length = 21 days) and the subsequent doses were titrated up to 1.75mg/kg Q3W via Fibonacci scheme, on Day 1 of each cycle for up to 87 cycles (for up to approximately 5 years).
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|---|---|
|
Percentage of Participants With Modified Erythroid Response (mHI-E) Per International Working Group (IWG) 2006 Response Criteria
|
81.3 Percentage of participants
Interval 70.7 to 89.4
|
SECONDARY outcome
Timeframe: Any consecutive 8 weeks during the study (up to approximately 5 years)Population: All enrolled participants who received at least one dose of luspatercept and were HI-E evaluable.
Per IWG 2006 response criteria, the rate of HI-E was defined as the percentage of participants with an HI-E response by an Hgb increase of ≥1.5 g/dL for participants not transfused or as defined by having received less than 4 units of RBCs within 8 weeks of baseline or reduction by ≥4 units of RBCs transfused (for a Hgb≤9.0 g/dL) during any 8-week period on study, compared with the 8-week period prior to study day 1.
Outcome measures
| Measure |
Luspatercept Extension Population
n=75 Participants
Participants received luspatercept dose of either 0.5, 0.75, 1.0, 1.33, or 1.75 mg/kg determined via Fibonacci scheme on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years) as a subcutaneous (SC) injection. Direct Roll Over participants received the highest tolerated dose of luspatercept that was assigned in the base study. Treatment Interrupted participants received an initial dose of luspatercept 1mg/kg on Day 1 of Cycle 1 (cycle length = 21 days) and the subsequent doses were titrated up to 1.75mg/kg Q3W via Fibonacci scheme, on Day 1 of each cycle for up to 87 cycles (for up to approximately 5 years).
|
|---|---|
|
Rate of Erythroid Response (HI-E) Per IWG 2006 Response Criteria
|
80.0 Percentage of participants
Interval 69.2 to 88.4
|
SECONDARY outcome
Timeframe: Any consecutive 8 Weeks during the study (up to approximately 5 years)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 response was defined for participants with baseline absolute neutrophil count (ANC) \<1.0×10\^9/L as the percentage increase ≥100% and an absolute mean increase \>0.5 ×10\^9/L during any rolling 8-week window on treatment compared with baseline. The rolling 8-week was defined as any consecutive 8 weeks during the study. Percentage of participants with HI-N response were reported.
Outcome measures
| Measure |
Luspatercept Extension Population
n=14 Participants
Participants received luspatercept dose of either 0.5, 0.75, 1.0, 1.33, or 1.75 mg/kg determined via Fibonacci scheme on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years) as a subcutaneous (SC) injection. Direct Roll Over participants received the highest tolerated dose of luspatercept that was assigned in the base study. Treatment Interrupted participants received an initial dose of luspatercept 1mg/kg on Day 1 of Cycle 1 (cycle length = 21 days) and the subsequent doses were titrated up to 1.75mg/kg Q3W via Fibonacci scheme, on Day 1 of each cycle for up to 87 cycles (for up to approximately 5 years).
|
|---|---|
|
Rate of Neutrophil Response (HI-N) Per IWG 2006 Response Criteria
|
64.3 Percentage of participants
Interval 35.1 to 87.2
|
SECONDARY outcome
Timeframe: Any consecutive 8 Weeks during the study (up to approximately 5 years)Population: All enrolled participants who received at least one dose of luspatercept and had baseline platelet \<100x10\^9/L.
Per IWG 2006 response criteria, HI-P response was defined for participants with baseline platelet count \<100×10\^9/L as the following: 1) For participants with baseline ≥20×10\^9/L, an absolute increase of ≥30×10\^9/L during any rolling 8-week window on treatment and 2) For participants with baseline \<20×10\^9/L, mean value of \>20×10\^9/L and percentage increase ≥100% during any rolling 8-week window on treatment. The rolling 8-week was defined as any consecutive 8 weeks during the study. Percentage of participants with HI-P response were reported.
Outcome measures
| Measure |
Luspatercept Extension Population
n=11 Participants
Participants received luspatercept dose of either 0.5, 0.75, 1.0, 1.33, or 1.75 mg/kg determined via Fibonacci scheme on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years) as a subcutaneous (SC) injection. Direct Roll Over participants received the highest tolerated dose of luspatercept that was assigned in the base study. Treatment Interrupted participants received an initial dose of luspatercept 1mg/kg on Day 1 of Cycle 1 (cycle length = 21 days) and the subsequent doses were titrated up to 1.75mg/kg Q3W via Fibonacci scheme, on Day 1 of each cycle for up to 87 cycles (for up to approximately 5 years).
|
|---|---|
|
Rate of Platelet Response (HI-P) Per IWG 2006 Response Criteria
|
36.4 Percentage of participants
Interval 10.9 to 69.2
|
SECONDARY outcome
Timeframe: up to approximately 5 yearsPopulation: All enrolled LTB participants who received at least one dose of luspatercept and had a HI-E.
For LTB participants, HI-E was defined as all Hgb increase ≥1.5 g/dL during any rolling 8 weeks window. LTB participants were those who received \<4 units of RBCs within 8 weeks prior to baseline. Per IWG 2006 response criteria, duration of HI-E was defined as the time from the first day of the first rolling 8 weeks interval of showing response to the last day of the last consecutive rolling 8 weeks interval of showing response. Rolling 8 weeks was defined as any consecutive 8 weeks during the study. When there were multiple disjointed intervals with response, the longest interval was used.
Outcome measures
| Measure |
Luspatercept Extension Population
n=50 Participants
Participants received luspatercept dose of either 0.5, 0.75, 1.0, 1.33, or 1.75 mg/kg determined via Fibonacci scheme on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years) as a subcutaneous (SC) injection. Direct Roll Over participants received the highest tolerated dose of luspatercept that was assigned in the base study. Treatment Interrupted participants received an initial dose of luspatercept 1mg/kg on Day 1 of Cycle 1 (cycle length = 21 days) and the subsequent doses were titrated up to 1.75mg/kg Q3W via Fibonacci scheme, on Day 1 of each cycle for up to 87 cycles (for up to approximately 5 years).
|
|---|---|
|
Duration of HI-E in LTB Participants Per IWG 2006 Response Criteria
|
299 Days
Standard Deviation 378.3
|
SECONDARY outcome
Timeframe: up to approximately 5 yearsPopulation: All enrolled HTB participants who received at lease one dose of luspatercept and had a HI-E.
For HTB participants, HI-E was defined as RBC transfusion reduction ≥4 units during any rolling 8 weeks. HTB participants were those who required a transfusion of ≥4 units of RBCs in the 8 weeks prior to baseline. Per IWG 2006 response criteria, duration of HI-E was defined as the time from the first day of the first rolling 8 weeks interval of showing response to the last day of the last consecutive rolling 8 weeks interval of showing response. Rolling 8 weeks was defined as any consecutive 8 weeks during the study. When there were multiple disjointed intervals with response, the longest interval was used.
Outcome measures
| Measure |
Luspatercept Extension Population
n=25 Participants
Participants received luspatercept dose of either 0.5, 0.75, 1.0, 1.33, or 1.75 mg/kg determined via Fibonacci scheme on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years) as a subcutaneous (SC) injection. Direct Roll Over participants received the highest tolerated dose of luspatercept that was assigned in the base study. Treatment Interrupted participants received an initial dose of luspatercept 1mg/kg on Day 1 of Cycle 1 (cycle length = 21 days) and the subsequent doses were titrated up to 1.75mg/kg Q3W via Fibonacci scheme, on Day 1 of each cycle for up to 87 cycles (for up to approximately 5 years).
|
|---|---|
|
Duration of HI-E in HTB Participants Per IWG 2006 Response Criteria
|
328 Days
Standard Deviation 286.8
|
SECONDARY outcome
Timeframe: up to approximately 5 yearsPopulation: All enrolled LTB participants who received at least one dose of luspatercept and had a HI-E.
For LTB participants, HI-E was defined as all Hgb increase ≥1.5 g/dL during any rolling 8 weeks window. LTB participants were those who received \<4 units of RBCs within 8 weeks prior to baseline. Per IWG 2006 response criteria, time to HI-E was defined as the first date of the rolling 8 weeks interval of showing response minus first dose date plus 1. Rolling 8 weeks was defined as any consecutive 8 weeks during the study. When there were multiple disjointed intervals with response, the longest interval was used.
Outcome measures
| Measure |
Luspatercept Extension Population
n=50 Participants
Participants received luspatercept dose of either 0.5, 0.75, 1.0, 1.33, or 1.75 mg/kg determined via Fibonacci scheme on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years) as a subcutaneous (SC) injection. Direct Roll Over participants received the highest tolerated dose of luspatercept that was assigned in the base study. Treatment Interrupted participants received an initial dose of luspatercept 1mg/kg on Day 1 of Cycle 1 (cycle length = 21 days) and the subsequent doses were titrated up to 1.75mg/kg Q3W via Fibonacci scheme, on Day 1 of each cycle for up to 87 cycles (for up to approximately 5 years).
|
|---|---|
|
Time to HI-E in LTB Participants Per IWG 2006 Response Criteria
|
83 Days
Standard Deviation 86.2
|
SECONDARY outcome
Timeframe: Any consecutive 8 weeks during the study (up to approximately 5 years)Population: All enrolled HTB participants who received at lease one dose of luspatercept and had a HI-E.
For HTB participants, HI-E was defined as RBC transfusion reduction ≥4 units during any rolling 8 weeks. HTB participants were those who required a transfusion of ≥4 units of RBCs in the 8 weeks prior to baseline. Per IWG 2006 response criteria, time to HI-E was defined as the first date of the rolling 8 weeks interval of showing response minus first dose date plus 1. Rolling 8 weeks was defined as any consecutive 8 weeks during the study.
Outcome measures
| Measure |
Luspatercept Extension Population
n=25 Participants
Participants received luspatercept dose of either 0.5, 0.75, 1.0, 1.33, or 1.75 mg/kg determined via Fibonacci scheme on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years) as a subcutaneous (SC) injection. Direct Roll Over participants received the highest tolerated dose of luspatercept that was assigned in the base study. Treatment Interrupted participants received an initial dose of luspatercept 1mg/kg on Day 1 of Cycle 1 (cycle length = 21 days) and the subsequent doses were titrated up to 1.75mg/kg Q3W via Fibonacci scheme, on Day 1 of each cycle for up to 87 cycles (for up to approximately 5 years).
|
|---|---|
|
Time to HI-E in HTB Participants Per IWG 2006 Response Criteria
|
13 Days
Standard Deviation 22.6
|
SECONDARY outcome
Timeframe: Any consecutive 8 Weeks during the study (up to approximately 5 years)Population: All enrolled participants who received at least one dose of luspatercept and had ≥2 units of RBC transfusions at baseline.
Per protocol, RBC-TI response was defined as not requiring RBC transfusion for 8 or more weeks while on treatment among participants with ≥2 units of RBC transfusions at baseline. The rate of RBC-TI was defined as the percentage of participants with ≥2 units of RBC transfusions at baseline with RBC-TI.
Outcome measures
| Measure |
Luspatercept Extension Population
n=42 Participants
Participants received luspatercept dose of either 0.5, 0.75, 1.0, 1.33, or 1.75 mg/kg determined via Fibonacci scheme on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years) as a subcutaneous (SC) injection. Direct Roll Over participants received the highest tolerated dose of luspatercept that was assigned in the base study. Treatment Interrupted participants received an initial dose of luspatercept 1mg/kg on Day 1 of Cycle 1 (cycle length = 21 days) and the subsequent doses were titrated up to 1.75mg/kg Q3W via Fibonacci scheme, on Day 1 of each cycle for up to 87 cycles (for up to approximately 5 years).
|
|---|---|
|
Rate of RBC Transfusion Independence (RBC-TI)
|
64.3 Percentage of participants
Interval 48.0 to 78.4
|
SECONDARY outcome
Timeframe: Baseline and up to 5 yearsPopulation: All enrolled HTB participants who received at least one dose of luspatercept.
RBC TB was defined as ≥4 units or 50% reduction during rolling 8 weeks among HTB participants. The rolling 8-week was defined as any consecutive 8 weeks during the study. HTB participants are those who required a transfusion of ≥4 units of RBCs in the 8 weeks prior to baseline. Mean change from baseline to Week 8 in reduction in RBC TD in HTB participants was reported.
Outcome measures
| Measure |
Luspatercept Extension Population
n=25 Participants
Participants received luspatercept dose of either 0.5, 0.75, 1.0, 1.33, or 1.75 mg/kg determined via Fibonacci scheme on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years) as a subcutaneous (SC) injection. Direct Roll Over participants received the highest tolerated dose of luspatercept that was assigned in the base study. Treatment Interrupted participants received an initial dose of luspatercept 1mg/kg on Day 1 of Cycle 1 (cycle length = 21 days) and the subsequent doses were titrated up to 1.75mg/kg Q3W via Fibonacci scheme, on Day 1 of each cycle for up to 87 cycles (for up to approximately 5 years).
|
|---|---|
|
Mean Change From Baseline to Week 8 in RBC Transfusion Burden (TB) in HTB Participants
|
-4.4 Units of blood
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: All enrolled LTB participants who received at least one dose of luspatercept.
Baseline hemoglobin levels were the documented pre-transfusion hemoglobin values during the 12 weeks prior to treatment. LTB participants were those who received \<4 units of RBCs within 8 weeks prior to baseline. Mean change from baseline to Week 8 in hemoglobin levels ≥1.5 grams/dL in LTB participants were reported.
Outcome measures
| Measure |
Luspatercept Extension Population
n=50 Participants
Participants received luspatercept dose of either 0.5, 0.75, 1.0, 1.33, or 1.75 mg/kg determined via Fibonacci scheme on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years) as a subcutaneous (SC) injection. Direct Roll Over participants received the highest tolerated dose of luspatercept that was assigned in the base study. Treatment Interrupted participants received an initial dose of luspatercept 1mg/kg on Day 1 of Cycle 1 (cycle length = 21 days) and the subsequent doses were titrated up to 1.75mg/kg Q3W via Fibonacci scheme, on Day 1 of each cycle for up to 87 cycles (for up to approximately 5 years).
|
|---|---|
|
Mean Change From Baseline to Week 8 in Hemoglobin Levels ≥1.5 Grams/dL in LTB Participants
|
2.4 grams/dl
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Day 1: Cycles 1, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, and 81 (each cycle length = 21 days); End of treatment (EOT) Day 1853Population: All participants who received at least one dose of luspatercept and had data available for serum concentration analysis available at each time point.
Blood samples were collected at pre-determined time points to determine the serum concentration of luspatercept. Serum concentrations that were below the limit of quantitation (LOQ) of the assay prior to the first dose were assigned a numerical value of zero. Post-treatment serum concentrations that were below the LOQ of the assay were treated as missing. Serum concentrations assigned a value of missing were omitted from the analysis. The LOQ of the assay was 50 ng/mL.
Outcome measures
| Measure |
Luspatercept Extension Population
n=55 Participants
Participants received luspatercept dose of either 0.5, 0.75, 1.0, 1.33, or 1.75 mg/kg determined via Fibonacci scheme on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years) as a subcutaneous (SC) injection. Direct Roll Over participants received the highest tolerated dose of luspatercept that was assigned in the base study. Treatment Interrupted participants received an initial dose of luspatercept 1mg/kg on Day 1 of Cycle 1 (cycle length = 21 days) and the subsequent doses were titrated up to 1.75mg/kg Q3W via Fibonacci scheme, on Day 1 of each cycle for up to 87 cycles (for up to approximately 5 years).
|
|---|---|
|
Serum Concentration of Luspatercept
Cycle 5 Day 1
|
6.373 µg/mL
Standard Deviation 3.527
|
|
Serum Concentration of Luspatercept
Cycle 25 Day 1
|
7.986 µg/mL
Standard Deviation 4.061
|
|
Serum Concentration of Luspatercept
Cycle 29 Day 1
|
8.379 µg/mL
Standard Deviation 2.884
|
|
Serum Concentration of Luspatercept
Cycle 33 Day 1
|
8.024 µg/mL
Standard Deviation 3.035
|
|
Serum Concentration of Luspatercept
Cycle 49 Day 1
|
9.447 µg/mL
Standard Deviation 2.967
|
|
Serum Concentration of Luspatercept
Cycle 53 Day 1
|
7.936 µg/mL
Standard Deviation 2.982
|
|
Serum Concentration of Luspatercept
Cycle 57 Day 1
|
8.891 µg/mL
Standard Deviation 3.053
|
|
Serum Concentration of Luspatercept
Cycle 77 Day 1
|
7.539 µg/mL
Standard Deviation 2.555
|
|
Serum Concentration of Luspatercept
Cycle 81 Day 1
|
9.837 µg/mL
Standard Deviation NA
NA = SD could not be calculated due to low number of participants with serum concentration of luspatercept.
|
|
Serum Concentration of Luspatercept
EOT (Day 1853)
|
6.732 µg/mL
Standard Deviation 4.356
|
|
Serum Concentration of Luspatercept
Cycle 1 Day 1
|
0.509 µg/mL
Standard Deviation 0.738
|
|
Serum Concentration of Luspatercept
Cycle 9 Day 1
|
6.589 µg/mL
Standard Deviation 4.32
|
|
Serum Concentration of Luspatercept
Cycle 13 Day 1
|
7.154 µg/mL
Standard Deviation 4.423
|
|
Serum Concentration of Luspatercept
Cycle 17 Day 1
|
8.136 µg/mL
Standard Deviation 4.476
|
|
Serum Concentration of Luspatercept
Cycle 21 Day 1
|
8.227 µg/mL
Standard Deviation 3.811
|
|
Serum Concentration of Luspatercept
Cycle 37 Day 1
|
8.017 µg/mL
Standard Deviation 3.724
|
|
Serum Concentration of Luspatercept
Cycle 41 Day 1
|
7.559 µg/mL
Standard Deviation 3.582
|
|
Serum Concentration of Luspatercept
Cycle 45 Day 1
|
8.614 µg/mL
Standard Deviation 4.015
|
|
Serum Concentration of Luspatercept
Cycle 61 Day 1
|
8.288 µg/mL
Standard Deviation 3.753
|
|
Serum Concentration of Luspatercept
Cycle 65 Day 1
|
8.698 µg/mL
Standard Deviation 4.729
|
|
Serum Concentration of Luspatercept
Cycle 69 Day 1
|
7.603 µg/mL
Standard Deviation 3.144
|
|
Serum Concentration of Luspatercept
Cycle 73 Day 1
|
8.559 µg/mL
Standard Deviation 3.68
|
SECONDARY outcome
Timeframe: Baseline (prior to first dose of luspatercept) and Day 1853Population: All enrolled participants who received at least one dose of luspatercept and had data available for serum iron.
Blood samples were collected at pre-specified time intervals to determine serum iron concentration. The percentage change from baseline to Day 1853 in concentration of serum iron was reported.
Outcome measures
| Measure |
Luspatercept Extension Population
n=55 Participants
Participants received luspatercept dose of either 0.5, 0.75, 1.0, 1.33, or 1.75 mg/kg determined via Fibonacci scheme on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years) as a subcutaneous (SC) injection. Direct Roll Over participants received the highest tolerated dose of luspatercept that was assigned in the base study. Treatment Interrupted participants received an initial dose of luspatercept 1mg/kg on Day 1 of Cycle 1 (cycle length = 21 days) and the subsequent doses were titrated up to 1.75mg/kg Q3W via Fibonacci scheme, on Day 1 of each cycle for up to 87 cycles (for up to approximately 5 years).
|
|---|---|
|
Percent Change From Baseline to Day 1853 in Concentration of Serum Iron
|
20.38 Percent change
Standard Deviation 70.489
|
SECONDARY outcome
Timeframe: Baseline (prior to first dose of luspatercept) and Day 1853Population: 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 to Day 1853 in TIBC was reported.
Outcome measures
| Measure |
Luspatercept Extension Population
n=55 Participants
Participants received luspatercept dose of either 0.5, 0.75, 1.0, 1.33, or 1.75 mg/kg determined via Fibonacci scheme on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years) as a subcutaneous (SC) injection. Direct Roll Over participants received the highest tolerated dose of luspatercept that was assigned in the base study. Treatment Interrupted participants received an initial dose of luspatercept 1mg/kg on Day 1 of Cycle 1 (cycle length = 21 days) and the subsequent doses were titrated up to 1.75mg/kg Q3W via Fibonacci scheme, on Day 1 of each cycle for up to 87 cycles (for up to approximately 5 years).
|
|---|---|
|
Percent Change From Baseline to Day 1853 in Total Iron Binding Capacity (TIBC)
|
-11.37 Percent change
Standard Deviation 11.979
|
SECONDARY outcome
Timeframe: Baseline (prior to first dose of luspatercept) and Day 1853Population: All enrolled participants who received at least one dose of luspatercept and had data available for transferrin.
Blood samples were collected at pre-specified time intervals to determine serum transferrin concentration. The percentage change from baseline to Day 1853 in concentration of transferrin was reported.
Outcome measures
| Measure |
Luspatercept Extension Population
n=55 Participants
Participants received luspatercept dose of either 0.5, 0.75, 1.0, 1.33, or 1.75 mg/kg determined via Fibonacci scheme on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years) as a subcutaneous (SC) injection. Direct Roll Over participants received the highest tolerated dose of luspatercept that was assigned in the base study. Treatment Interrupted participants received an initial dose of luspatercept 1mg/kg on Day 1 of Cycle 1 (cycle length = 21 days) and the subsequent doses were titrated up to 1.75mg/kg Q3W via Fibonacci scheme, on Day 1 of each cycle for up to 87 cycles (for up to approximately 5 years).
|
|---|---|
|
Percent Change From Baseline to Day 1853 in Concentration of Transferrin
|
-11.34 Percent change
Standard Deviation 11.587
|
SECONDARY outcome
Timeframe: Baseline (prior to first dose of luspatercept) and Day 1853Population: 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 to Day 1853 in concentration of soluble transferrin receptor was reported.
Outcome measures
| Measure |
Luspatercept Extension Population
n=55 Participants
Participants received luspatercept dose of either 0.5, 0.75, 1.0, 1.33, or 1.75 mg/kg determined via Fibonacci scheme on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years) as a subcutaneous (SC) injection. Direct Roll Over participants received the highest tolerated dose of luspatercept that was assigned in the base study. Treatment Interrupted participants received an initial dose of luspatercept 1mg/kg on Day 1 of Cycle 1 (cycle length = 21 days) and the subsequent doses were titrated up to 1.75mg/kg Q3W via Fibonacci scheme, on Day 1 of each cycle for up to 87 cycles (for up to approximately 5 years).
|
|---|---|
|
Percent Change From Baseline to Day 1853 in Concentration of Soluble Transferrin Receptor
|
11.52 Percent change
Standard Deviation 48.541
|
SECONDARY outcome
Timeframe: Baseline (prior to first dose of luspatercept) and Day 1853Population: 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 to Day 1853 in concentration of serum ferritin was reported.
Outcome measures
| Measure |
Luspatercept Extension Population
n=55 Participants
Participants received luspatercept dose of either 0.5, 0.75, 1.0, 1.33, or 1.75 mg/kg determined via Fibonacci scheme on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years) as a subcutaneous (SC) injection. Direct Roll Over participants received the highest tolerated dose of luspatercept that was assigned in the base study. Treatment Interrupted participants received an initial dose of luspatercept 1mg/kg on Day 1 of Cycle 1 (cycle length = 21 days) and the subsequent doses were titrated up to 1.75mg/kg Q3W via Fibonacci scheme, on Day 1 of each cycle for up to 87 cycles (for up to approximately 5 years).
|
|---|---|
|
Percent Change From Baseline to Day 1853 in Concentration of Serum Ferritin
|
71.61 Percent change
Standard Deviation 152.948
|
SECONDARY outcome
Timeframe: Baseline (prior to first dose of luspatercept) and Day 1853Population: No data were collected for the percent change from baseline to day 1853 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 1853Population: No data were collected for the percent change from baseline to day 1853 in concentration of serum hepcidin.
Blood samples were to be collected at pre-specified time intervals to determine concentration of serum hepcidin. 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 1853Population: All enrolled participants who received at least one dose of luspatercept and had data available for erythropoietin.
Blood samples were collected at pre-specified time intervals to determine serum erythropoietin concentration. The percentage change from baseline to Day 1853 in concentration of serum erythropoietin was reported.
Outcome measures
| Measure |
Luspatercept Extension Population
n=53 Participants
Participants received luspatercept dose of either 0.5, 0.75, 1.0, 1.33, or 1.75 mg/kg determined via Fibonacci scheme on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years) as a subcutaneous (SC) injection. Direct Roll Over participants received the highest tolerated dose of luspatercept that was assigned in the base study. Treatment Interrupted participants received an initial dose of luspatercept 1mg/kg on Day 1 of Cycle 1 (cycle length = 21 days) and the subsequent doses were titrated up to 1.75mg/kg Q3W via Fibonacci scheme, on Day 1 of each cycle for up to 87 cycles (for up to approximately 5 years).
|
|---|---|
|
Percent Change From Baseline to Day 1853 in Concentration of Serum Erythropoietin
|
2252.15 Percent change
Standard Deviation 14490.300
|
SECONDARY outcome
Timeframe: Baseline (prior to first dose of luspatercept) and Day 1853Population: All enrolled participants who received at least one dose of luspatercept and had data available for reticulocyte.
Blood samples were collected at pre-specified time intervals to determine reticulocyte count. The percentage change from baseline to Day 1853 in reticulocyte count was reported.
Outcome measures
| Measure |
Luspatercept Extension Population
n=47 Participants
Participants received luspatercept dose of either 0.5, 0.75, 1.0, 1.33, or 1.75 mg/kg determined via Fibonacci scheme on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years) as a subcutaneous (SC) injection. Direct Roll Over participants received the highest tolerated dose of luspatercept that was assigned in the base study. Treatment Interrupted participants received an initial dose of luspatercept 1mg/kg on Day 1 of Cycle 1 (cycle length = 21 days) and the subsequent doses were titrated up to 1.75mg/kg Q3W via Fibonacci scheme, on Day 1 of each cycle for up to 87 cycles (for up to approximately 5 years).
|
|---|---|
|
Percent Change From Baseline to Day 1853 in Reticulocyte Count
|
78.70 Percent change
Standard Deviation 137.168
|
SECONDARY outcome
Timeframe: Baseline (prior to first dose of luspatercept) and Day 1853Population: No data were collected for the percent change from baseline to day 1853 in nRBC count.
Blood samples were to be collected at pre-specified time intervals to determine 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 1853Population: 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 to Day 1853 in concentration of direct bilirubin was reported.
Outcome measures
| Measure |
Luspatercept Extension Population
n=47 Participants
Participants received luspatercept dose of either 0.5, 0.75, 1.0, 1.33, or 1.75 mg/kg determined via Fibonacci scheme on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years) as a subcutaneous (SC) injection. Direct Roll Over participants received the highest tolerated dose of luspatercept that was assigned in the base study. Treatment Interrupted participants received an initial dose of luspatercept 1mg/kg on Day 1 of Cycle 1 (cycle length = 21 days) and the subsequent doses were titrated up to 1.75mg/kg Q3W via Fibonacci scheme, on Day 1 of each cycle for up to 87 cycles (for up to approximately 5 years).
|
|---|---|
|
Percent Change From Baseline to Day 1853 in Direct Bilirubin Level
|
110.53 Percent change
Standard Deviation 572.494
|
SECONDARY outcome
Timeframe: Baseline (prior to first dose of luspatercept) and Day 1853Population: 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 to Day 1853 in concentration of total bilirubin was reported.
Outcome measures
| Measure |
Luspatercept Extension Population
n=57 Participants
Participants received luspatercept dose of either 0.5, 0.75, 1.0, 1.33, or 1.75 mg/kg determined via Fibonacci scheme on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years) as a subcutaneous (SC) injection. Direct Roll Over participants received the highest tolerated dose of luspatercept that was assigned in the base study. Treatment Interrupted participants received an initial dose of luspatercept 1mg/kg on Day 1 of Cycle 1 (cycle length = 21 days) and the subsequent doses were titrated up to 1.75mg/kg Q3W via Fibonacci scheme, on Day 1 of each cycle for up to 87 cycles (for up to approximately 5 years).
|
|---|---|
|
Percent Change From Baseline to Day 1853 in Total Bilirubin Level
|
72.17 Percent change
Standard Deviation 236.953
|
SECONDARY outcome
Timeframe: Baseline (prior to first dose of luspatercept) and Day 1853Population: 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 to Day 1853 in concentration of lactate dehydrogenase level was reported.
Outcome measures
| Measure |
Luspatercept Extension Population
n=55 Participants
Participants received luspatercept dose of either 0.5, 0.75, 1.0, 1.33, or 1.75 mg/kg determined via Fibonacci scheme on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years) as a subcutaneous (SC) injection. Direct Roll Over participants received the highest tolerated dose of luspatercept that was assigned in the base study. Treatment Interrupted participants received an initial dose of luspatercept 1mg/kg on Day 1 of Cycle 1 (cycle length = 21 days) and the subsequent doses were titrated up to 1.75mg/kg Q3W via Fibonacci scheme, on Day 1 of each cycle for up to 87 cycles (for up to approximately 5 years).
|
|---|---|
|
Percent Change From Baseline to Day 1853 in Lactate Dehydrogenase Level
|
22.98 Percent change
Standard Deviation 43.017
|
SECONDARY outcome
Timeframe: Baseline (prior to first dose of luspatercept) and Day 1853Population: No data were collected for the percent change from baseline to day 1853 in concentration of BSAP.
Blood samples were to be collected at pre-specified time intervals to determine BSAP. 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 1853Population: No data were collected for the percent change from baseline to day 1853 in concentration of CTX.
Blood samples were to be collected at pre-specified time intervals to determine CTX. Baseline was prespecified to be the last measurement prior to the first dose of study drug.
Outcome measures
Outcome data not reported
Adverse Events
Luspatercept 0.5 mg/kg
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Luspatercept 0.75 mg/kg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Luspatercept 1 mg/kg
Serious events: 19 serious events
Other events: 44 other events
Deaths: 4 deaths
Luspatercept 1.33 mg/kg
Serious events: 16 serious events
Other events: 29 other events
Deaths: 3 deaths
Luspatercept 1.75 mg/kg
Serious events: 34 serious events
Other events: 38 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Luspatercept 0.5 mg/kg
n=1 participants at risk
Participants received luspatercept dose of 0.5 mg/kg on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years).
|
Luspatercept 0.75 mg/kg
n=2 participants at risk
Participants received luspatercept dose of 0.75 mg/kg on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years).
|
Luspatercept 1 mg/kg
n=73 participants at risk
Participants received luspatercept dose of 1 mg/kg on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years).
|
Luspatercept 1.33 mg/kg
n=61 participants at risk
Participants received luspatercept dose of 1.33 mg/kg on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years).
|
Luspatercept 1.75 mg/kg
n=49 participants at risk
Participants received luspatercept dose of 1.75 mg/kg on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years).
|
|---|---|---|---|---|---|
|
Eye disorders
Papilloedema
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.7%
2/73 • Number of events 3 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
4.1%
2/49 • Number of events 3 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
4.1%
2/49 • Number of events 2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Eye disorders
Keratitis
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Gastrointestinal disorders
Gastrointestinal polyp haemorrhage
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
General disorders
Asthenia
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
General disorders
Fatigue
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
General disorders
Gait disturbance
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
General disorders
General physical health deterioration
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
General disorders
Sudden death
|
100.0%
1/1 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Immune system disorders
Autoinflammatory disease
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Infections and infestations
Abscess
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Infections and infestations
Device related infection
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
4.1%
2/49 • Number of events 2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
8.2%
4/49 • Number of events 5 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Infections and infestations
Haematoma infection
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Infections and infestations
Infection
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Infections and infestations
Influenza
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.7%
2/73 • Number of events 2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
3.3%
2/61 • Number of events 2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
6.1%
3/49 • Number of events 3 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Infections and infestations
Sepsis
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
8.2%
4/49 • Number of events 5 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Infections and infestations
Staphylococcal osteomyelitis
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.7%
2/73 • Number of events 2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Infections and infestations
Viral infection
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.7%
2/73 • Number of events 2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
6.1%
3/49 • Number of events 3 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.7%
2/73 • Number of events 2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
4.1%
2/49 • Number of events 2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myelomonocytic leukaemia
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
50.0%
1/2 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
6.1%
3/49 • Number of events 3 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
4.1%
2/49 • Number of events 2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transformation to acute myeloid leukaemia
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
4.9%
3/61 • Number of events 3 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
3.3%
2/61 • Number of events 2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
4.1%
3/73 • Number of events 4 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
4.1%
2/49 • Number of events 2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Vascular disorders
Temporal arteritis
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
Other adverse events
| Measure |
Luspatercept 0.5 mg/kg
n=1 participants at risk
Participants received luspatercept dose of 0.5 mg/kg on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years).
|
Luspatercept 0.75 mg/kg
n=2 participants at risk
Participants received luspatercept dose of 0.75 mg/kg on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years).
|
Luspatercept 1 mg/kg
n=73 participants at risk
Participants received luspatercept dose of 1 mg/kg on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years).
|
Luspatercept 1.33 mg/kg
n=61 participants at risk
Participants received luspatercept dose of 1.33 mg/kg on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years).
|
Luspatercept 1.75 mg/kg
n=49 participants at risk
Participants received luspatercept dose of 1.75 mg/kg on Day 1 of each 21-day cycle for up to 87 cycles (up to approximately 5 years).
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
3.3%
2/61 • Number of events 4 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
10.2%
5/49 • Number of events 5 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
10.2%
5/49 • Number of events 7 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
50.0%
1/2 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
8.2%
4/49 • Number of events 12 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.7%
2/73 • Number of events 2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
6.1%
3/49 • Number of events 4 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
5.5%
4/73 • Number of events 5 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
6.1%
3/49 • Number of events 4 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
11.0%
8/73 • Number of events 8 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
4.9%
3/61 • Number of events 6 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
14.3%
7/49 • Number of events 9 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
3.3%
2/61 • Number of events 2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
10.2%
5/49 • Number of events 5 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
50.0%
1/2 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
General disorders
Fatigue
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
50.0%
1/2 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
11.0%
8/73 • Number of events 9 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
3.3%
2/61 • Number of events 3 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
12.2%
6/49 • Number of events 8 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
9.6%
7/73 • Number of events 10 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
4.9%
3/61 • Number of events 3 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
16.3%
8/49 • Number of events 14 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
General disorders
Pain
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.7%
2/73 • Number of events 3 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
6.1%
3/49 • Number of events 3 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
8.2%
4/49 • Number of events 7 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
5.5%
4/73 • Number of events 5 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
3.3%
2/61 • Number of events 4 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
8.2%
4/49 • Number of events 7 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
4.1%
3/73 • Number of events 11 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
6.6%
4/61 • Number of events 7 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
6.1%
3/49 • Number of events 5 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
8.2%
4/49 • Number of events 4 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
4.9%
3/61 • Number of events 3 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
6.1%
3/49 • Number of events 3 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
5.5%
4/73 • Number of events 4 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
10.2%
5/49 • Number of events 5 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
50.0%
1/2 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
5.5%
4/73 • Number of events 5 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
20.4%
10/49 • Number of events 18 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
17.8%
13/73 • Number of events 18 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
8.2%
5/61 • Number of events 7 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
20.4%
10/49 • Number of events 16 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
9.6%
7/73 • Number of events 8 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
4.1%
2/49 • Number of events 2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Investigations
Weight decreased
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
10.2%
5/49 • Number of events 5 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
12.2%
6/49 • Number of events 8 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
14.3%
7/49 • Number of events 7 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
50.0%
1/2 • Number of events 2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
4.1%
3/73 • Number of events 6 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
4.9%
3/61 • Number of events 6 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
8.2%
4/49 • Number of events 4 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
6.8%
5/73 • Number of events 5 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
3.3%
2/61 • Number of events 2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
4.1%
2/49 • Number of events 3 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
5.5%
4/73 • Number of events 4 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
6.6%
4/61 • Number of events 5 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
6.1%
3/49 • Number of events 3 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
50.0%
1/2 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
4.1%
3/73 • Number of events 5 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
3.3%
2/61 • Number of events 2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
6.1%
3/49 • Number of events 3 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
6.8%
5/73 • Number of events 13 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
10.2%
5/49 • Number of events 6 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
4.1%
3/73 • Number of events 4 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
6.1%
3/49 • Number of events 3 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
6.1%
3/49 • Number of events 3 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
6.1%
3/49 • Number of events 3 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
4.1%
3/73 • Number of events 6 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
8.2%
5/61 • Number of events 6 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
14.3%
7/49 • Number of events 9 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
4.1%
3/73 • Number of events 4 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
3.3%
2/61 • Number of events 2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
14.3%
7/49 • Number of events 8 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
4.1%
3/73 • Number of events 4 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
3.3%
2/61 • Number of events 2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
6.1%
3/49 • Number of events 3 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
50.0%
1/2 • Number of events 2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
6.8%
5/73 • Number of events 10 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
3.3%
2/61 • Number of events 2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
6.1%
3/49 • Number of events 8 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
4.1%
3/73 • Number of events 5 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
6.1%
3/49 • Number of events 3 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Vascular disorders
Haematoma
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
10.2%
5/49 • Number of events 9 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
24.7%
18/73 • Number of events 31 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
8.2%
5/61 • Number of events 6 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
4.1%
2/49 • Number of events 3 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
50.0%
1/2 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
6.1%
3/49 • Number of events 3 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Eye disorders
Macular degeneration
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
50.0%
1/2 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
50.0%
1/2 • Number of events 2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
6.1%
3/49 • Number of events 3 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
50.0%
1/2 • Number of events 2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Infections and infestations
Angular cheilitis
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
50.0%
1/2 • Number of events 2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
50.0%
1/2 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
2.0%
1/49 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
50.0%
1/2 • Number of events 2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.4%
1/73 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Vascular disorders
Hot flush
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
50.0%
1/2 • Number of events 2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/49 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/1 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/2 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/73 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
0.00%
0/61 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
6.1%
3/49 • Number of events 3 • up to approximately 5 years
All-cause mortality was reported on all enrolled participants. Serious and non-serious adverse events were reported on all participants who received at least one dose of luspatercept. Data are presented by the dose of luspatercept that was administered at the time when the AE or death occurred.
|
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 No publication or disclosure of study results will be permitted except as specified in a separate, written, agreement between the sponsor and the investigator(s).
- Publication restrictions are in place
Restriction type: OTHER