Extension Study to Evaluate Long-Term Effects of Luspater... | NCT02268383

ID	Type	Description
MK-6143-003	Other Identifier	Merck
A536-05	Other Identifier	Acceleron
2014-001280-13	EudraCT Number

Label	Type	Description	Intervention Names
Luspatercept Extension population	Experimental	Luspatercept 1.0 mg/kg once every 3 weeks by subcutaneous injection.	Drug: Luspatercept

Name	Type	Description	Arm Group Labels	Other Names
Luspatercept	Drug	Luspatercept 1.0 mg/kg once every 3 weeks by subcutaneous injection.	Luspatercept Extension population

Measure	Description	Time Frame
Number of Participants Who Experienced an Adverse Event (AE)	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.	Up to approximately 5 years
Number of Participants Who Discontinued Study Treatment Due to an AE	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.	Up to approximately 5 years

Measure	Description	Time Frame
Percentage of Participants With Modified Erythroid Response (mHI-E) Per International Working Group (IWG) 2006 Response Criteria	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Completion of the treatment period in the base study MK-6143-001 (ClinicalTrials.gov Identifier: NCT01749514)
Adequate birth control measures
Patient is able to adhere to the study visit schedule, understand and comply with all protocol requirements
Patient understands and is able to provide written informed consent
In addition, patients with treatment interruption (defined as patients who complete their end-of-study visit in MK-6143-001 and cannot directly roll over to MK-6143-003) must also meet the following criteria:
- Documented diagnosis of idiopathic/de novo MDS or non-proliferative chronic myelomonocytic leukemia (CMML) according to the World Health Organization (WHO) criteria 16 (white blood count (WBC) < 13,000/μL) that meets International Prognostic Scoring System (IPSS) classification of low or intermediate-1 risk disease as determined by microscopic and standard cytogenetic analyses of the bone marrow and peripheral complete blood count (CBC) obtained during screening;
Anemia defined as:
- Mean hemoglobin concentration < 10.0 g/dL of 2 measurements (one performed within one day prior to Cycle 1 Day 1 and the other performed 7-28 days prior to Cycle 1 Day 1), for non-transfusion dependent (NTD) patients (defined as having received ˂ 4 units of red blood cells (RBCs) within 8 weeks prior to Cycle 1 Day 1), OR
- Transfusion Dependent (TD), defined as having received ≥ 4 units of RBCs within 8 weeks prior to Cycle 1 Day 1
Platelet count ≥ 30 x 109/L
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (if related to anemia)
Adequate renal (creatinine ≤ 2.0 x upper limit of normal [ULN]) and hepatic (total bilirubin < 2 x ULN and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x ULN) function

Exclusion Criteria:

Discontinuation/withdrawal from the base study A536-03 (due to patient request, patient unwillingness or inability to comply with the protocol, pregnancy, use of prohibited medication [e.g. azacitidine], medical reason or adverse event (AE), hypersensitivity reaction to the study drug, at the discretion of the sponsor, or loss to follow-up) prior to completion of the treatment period
Prior treatment with azacitidine or decitabine
Treatment within 28 days prior to Cycle 1 Day 1 with:
- An erythropoiesis-stimulating agent (ESA),
- Granulocyte colony-stimulating factor (G-CSF) and granulocyte-macrophage colony stimulating factor (GM-CSF),
- Lenalidomide
Iron chelation therapy if initiated within 56 days prior to Cycle 1 Day 1
Treatment with another investigational drug (including sotatercept [ACE-011]) or device, or approved therapy for investigational use ≤ 28 days prior to Cycle 1 Day 1, or if the half-life of the previous investigational product is known, within 5 times the half-life prior to Cycle 1 Day 1, whichever is longer
Major surgery within 28 days prior to Cycle 1 Day 1. Patients must have completely recovered from any previous surgery prior to Cycle 1 Day 1
Known positive for human immunodeficiency virus (HIV), active infectious hepatitis B (HBV) or active infectious hepatitis C (HCV)
Uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 150 mm Hg or diastolic blood pressure (DBP) ≥ 100 mm Hg
Pregnant or lactating females
History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational drug
Any other condition not specifically noted above which, in the judgment of the investigator, would preclude the patient from participating in the study

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

PubMed Identifier	Type	Citation	Retractions
35998303	Derived	Platzbecker U, Gotze KS, Kiewe P, Germing U, Mayer K, Radsak M, Wolff T, Chromik J, Sockel K, Oelschlagel U, Haase D, Illmer T, Al-Ali HK, Silling G, Reynolds JG, Zhang X, Attie KM, Shetty JK, Giagounidis A. Long-Term Efficacy and Safety of Luspatercept for Anemia Treatment in Patients With Lower-Risk Myelodysplastic Syndromes: The Phase II PACE-MDS Study. J Clin Oncol. 2022 Nov 20;40(33):3800-3807. doi: 10.1200/JCO.21.02476. Epub 2022 Aug 23.
28870615

ID	Title	Description
FG000	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).

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 29, 2019	Apr 11, 2023

ID	Title	Description
BG000	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).

Units	Counts
Participants	BG00075

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants Who Experienced an Adverse Event (AE)

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.

All enrolled participants who received at least one dose of luspatercept.

Posted

Count of Participants

Participants

Up to approximately 5 years

ID	Title	Description
OG000	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).

Units	Counts
Participants	OG00075

Title

Denominators

Categories

Title	Measurements
	OG00075

Primary

Number of Participants Who Discontinued Study Treatment Due to an AE

All enrolled participants who received at least one dose of luspatercept.

Posted

Count of Participants

Participants

Up to approximately 5 years

ID	Title	Description
OG000	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).

Units

Secondary

Percentage of Participants With Modified Erythroid Response (mHI-E) Per International Working Group (IWG) 2006 Response Criteria

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.

All enrolled participants who received at least one dose of luspatercept and were mHI-E evaluable.

Posted

Number

95% Confidence Interval

Percentage of participants

Any consecutive 8 weeks during the study (up to approximately 5 years)

ID	Title	Description
OG000	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).

Secondary

Rate of Erythroid Response (HI-E) Per IWG 2006 Response Criteria

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.

All enrolled participants who received at least one dose of luspatercept and were HI-E evaluable.

Posted

Number

95% Confidence Interval

Percentage of participants

Any consecutive 8 weeks during the study (up to approximately 5 years)

ID	Title	Description
OG000	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).

Units	Counts

Secondary

Rate of Neutrophil Response (HI-N) Per IWG 2006 Response Criteria

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.

All enrolled participants who received at least one dose of luspatercept and had baseline neutrophil count <1.0×10^9/L.

Posted

Number

95% Confidence Interval

Percentage of participants

Any consecutive 8 Weeks during the study (up to approximately 5 years)

ID	Title	Description
OG000	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).

Units

Secondary

Rate of Platelet Response (HI-P) Per IWG 2006 Response Criteria

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.

All enrolled participants who received at least one dose of luspatercept and had baseline platelet <100x10^9/L.

Posted

Number

95% Confidence Interval

Percentage of participants

Any consecutive 8 Weeks during the study (up to approximately 5 years)

ID	Title	Description
OG000	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).

Secondary

Duration of HI-E in LTB Participants Per IWG 2006 Response Criteria

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.

All enrolled LTB participants who received at least one dose of luspatercept and had a HI-E.

Posted

Mean

Standard Deviation

Days

up to approximately 5 years

ID	Title	Description
OG000	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).

Secondary

Duration of HI-E in HTB Participants Per IWG 2006 Response Criteria

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.

All enrolled HTB participants who received at lease one dose of luspatercept and had a HI-E.

Posted

Mean

Standard Deviation

Days

up to approximately 5 years

ID	Title	Description
OG000	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).

Secondary

Time to HI-E in LTB Participants Per IWG 2006 Response Criteria

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.

All enrolled LTB participants who received at least one dose of luspatercept and had a HI-E.

Posted

Mean

Standard Deviation

Days

up to approximately 5 years

ID	Title	Description
OG000	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).

Units

Secondary

Time to HI-E in HTB Participants Per IWG 2006 Response Criteria

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.

All enrolled HTB participants who received at lease one dose of luspatercept and had a HI-E.

Posted

Mean

Standard Deviation

Days

Any consecutive 8 weeks during the study (up to approximately 5 years)

ID	Title	Description
OG000	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).

Units	Counts

Secondary

Rate of RBC Transfusion Independence (RBC-TI)

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.

All enrolled participants who received at least one dose of luspatercept and had ≥2 units of RBC transfusions at baseline.

Posted

Number

95% Confidence Interval

Percentage of participants

Any consecutive 8 Weeks during the study (up to approximately 5 years)

ID	Title	Description
OG000	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).

Units	Counts
Participants

Secondary

Mean Change From Baseline to Week 8 in RBC Transfusion Burden (TB) in HTB Participants

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.

All enrolled HTB participants who received at least one dose of luspatercept.

Posted

Mean

Standard Deviation

Units of blood

Baseline and up to 5 years

ID	Title	Description
OG000	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).

Units	Counts
Participants

Secondary

Mean Change From Baseline to Week 8 in Hemoglobin Levels ≥1.5 Grams/dL in LTB Participants

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.

All enrolled LTB participants who received at least one dose of luspatercept.

Posted

Mean

Standard Deviation

grams/dl

Baseline and Week 8

ID	Title	Description
OG000	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).

Units	Counts
Participants

Secondary

Serum Concentration of Luspatercept

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.

All participants who received at least one dose of luspatercept and had data available for serum concentration analysis available at each time point.

Posted

Mean

Standard Deviation

µg/mL

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 1853

ID	Title	Description
OG000	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).

Secondary

Percent Change From Baseline to Day 1853 in Concentration of 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.

All enrolled participants who received at least one dose of luspatercept and had data available for serum iron.

Posted

Mean

Standard Deviation

Percent change

Baseline (prior to first dose of luspatercept) and Day 1853

ID	Title	Description
OG000	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).

Units	Counts
Participants

Secondary

Percent Change From Baseline to Day 1853 in Total Iron Binding Capacity (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.

All enrolled participants who received at least one dose of luspatercept and had data available for TIBC.

Posted

Mean

Standard Deviation

Percent change

Baseline (prior to first dose of luspatercept) and Day 1853

ID	Title	Description
OG000	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).

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline to Day 1853 in Concentration of 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.

All enrolled participants who received at least one dose of luspatercept and had data available for transferrin.

Posted

Mean

Standard Deviation

Percent change

Baseline (prior to first dose of luspatercept) and Day 1853

ID	Title	Description
OG000	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).

Units	Counts
Participants

Secondary

Percent Change From Baseline to Day 1853 in Concentration of 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.

All enrolled participants who received at least one dose of luspatercept and had data available for soluble transferrin receptor.

Posted

Mean

Standard Deviation

Percent change

Baseline (prior to first dose of luspatercept) and Day 1853

ID	Title	Description
OG000	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).

Units	Counts
Participants

Secondary

Percent Change From Baseline to Day 1853 in Concentration of 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.

All enrolled participants who received at least one dose of luspatercept and had data available for serum ferritin.

Posted

Mean

Standard Deviation

Percent change

Baseline (prior to first dose of luspatercept) and Day 1853

ID	Title	Description
OG000	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).

Units	Counts
Participants

Secondary

Percent Change From Baseline to Day 1853 in Concentration of Non-Transferrin Bound Iron (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.

No data were collected for the percent change from baseline to day 1853 in concentration of NTBI.

Posted

Baseline (prior to first dose of luspatercept) and Day 1853

ID	Title	Description
OG000	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).

Units	Counts
Participants	OG000

Secondary

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.

No data were collected for the percent change from baseline to day 1853 in concentration of serum hepcidin.

Posted

Baseline (prior to first dose of luspatercept) and Day 1853

ID	Title	Description
OG000	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).

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline to Day 1853 in Concentration of Serum 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.

All enrolled participants who received at least one dose of luspatercept and had data available for erythropoietin.

Posted

Mean

Standard Deviation

Percent change

Baseline (prior to first dose of luspatercept) and Day 1853

ID	Title	Description
OG000	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).

Units	Counts
Participants

Secondary

Percent Change From Baseline to Day 1853 in Reticulocyte Count

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.

All enrolled participants who received at least one dose of luspatercept and had data available for reticulocyte.

Posted

Mean

Standard Deviation

Percent change

Baseline (prior to first dose of luspatercept) and Day 1853

ID	Title	Description
OG000	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).

Units	Counts
Participants

Secondary

Percent Change From Baseline to Day 1853 in Nucleated RBC (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.

No data were collected for the percent change from baseline to day 1853 in nRBC count.

Posted

Baseline (prior to first dose of luspatercept) and Day 1853

ID	Title	Description
OG000	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).

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline to Day 1853 in Direct Bilirubin Level

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.

All enrolled participants who received at least one dose of luspatercept and had data available for direct bilirubin.

Posted

Mean

Standard Deviation

Percent change

Baseline (prior to first dose of luspatercept) and Day 1853

ID	Title	Description
OG000	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).

Units	Counts
Participants

Secondary

Percent Change From Baseline to Day 1853 in Total Bilirubin Level

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.

All enrolled participants who received at least one dose of luspatercept and had data available for total bilirubin.

Posted

Mean

Standard Deviation

Percent change

Baseline (prior to first dose of luspatercept) and Day 1853

ID	Title	Description
OG000	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).

Units	Counts
Participants

Secondary

Percent Change From Baseline to Day 1853 in Lactate Dehydrogenase Level

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.

All enrolled participants who received at least one dose of luspatercept and had data available for lactate dehydrogenase.

Posted

Mean

Standard Deviation

Percent change

Baseline (prior to first dose of luspatercept) and Day 1853

ID	Title	Description
OG000	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).

Units	Counts
Participants

Secondary

Percent Change From Baseline to Day 1853 in Concentration of Serum Bone-Specific Alkaline Phosphatase (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.

No data were collected for the percent change from baseline to day 1853 in concentration of BSAP.

Posted

Baseline (prior to first dose of luspatercept) and Day 1853

ID	Title	Description
OG000	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).

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline to Day 1853 in Concentration of Serum Cross-Linked C-Telopeptide of Type I Collagen (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.

No data were collected for the percent change from baseline to day 1853 in concentration of CTX.

Posted

Baseline (prior to first dose of luspatercept) and Day 1853

ID	Title	Description
OG000	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).

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG0031 events1 affected61 at risk EG0040 events0 affected49 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Aortic valve stenosis	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0023 events2 affected73 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Cardiac failure chronic	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Sinus node dysfunction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Vestibular disorder	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Keratitis	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Papilloedema	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Retinal detachment	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Ulcerative keratitis	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Vitreous haemorrhage	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0022 events1 affected73 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Gastrointestinal polyp haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Asthenia	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Fatigue	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Gait disturbance	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
General physical health deterioration	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Pyrexia	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Sudden death	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Vessel puncture site haematoma	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Autoinflammatory disease	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Atypical pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Campylobacter gastroenteritis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Device related infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Erysipelas	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Haematoma infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Influenza	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Intervertebral discitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0022 events2 affected73 at risk EG003
Sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Staphylococcal osteomyelitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0022 events2 affected73 at risk EG003
Viral infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Bone contusion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Compression fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0022 events2 affected73 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0022 events2 affected73 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Chronic myelomonocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0011 events1 affected2 at risk EG0020 events0 affected73 at risk EG003
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Transformation to acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Ataxia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Normal pressure hydrocephalus	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Sciatica	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Syncope	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0024 events3 affected73 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Hallucination	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Prostatic obstruction	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Aortic stenosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Temporal arteritis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG0034 events2 affected61 at risk EG0045 events5 affected49 at risk
Splenomegaly	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0011 events1 affected2 at risk EG0021 events1 affected73 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0022 events2 affected73 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0025 events4 affected73 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0028 events8 affected73 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0011 events1 affected2 at risk EG0021 events1 affected73 at risk EG003
Fatigue	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0011 events1 affected2 at risk EG0029 events8 affected73 at risk EG003
Oedema peripheral	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG00210 events7 affected73 at risk EG003
Pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0023 events2 affected73 at risk EG003
Pyrexia	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Bronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0025 events4 affected73 at risk EG003
Oral herpes	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG00211 events3 affected73 at risk EG003
Pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0024 events4 affected73 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0011 events1 affected2 at risk EG0025 events4 affected73 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG00218 events13 affected73 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0028 events7 affected73 at risk EG003
Weight decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Folate deficiency	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0022 events1 affected73 at risk EG003
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0012 events1 affected2 at risk EG0026 events3 affected73 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0025 events5 affected73 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0024 events4 affected73 at risk EG003
Dizziness	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0011 events1 affected2 at risk EG0025 events3 affected73 at risk EG003
Headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG00213 events5 affected73 at risk EG003
Depression	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0024 events3 affected73 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0021 events1 affected73 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0026 events3 affected73 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0024 events3 affected73 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0024 events3 affected73 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0012 events1 affected2 at risk EG00210 events5 affected73 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0025 events3 affected73 at risk EG003
Haematoma	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG00231 events18 affected73 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0011 events1 affected2 at risk EG0020 events0 affected73 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Macular degeneration	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0011 events1 affected2 at risk EG0020 events0 affected73 at risk EG003
Mucosal inflammation	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0012 events1 affected2 at risk EG0021 events1 affected73 at risk EG003
Hepatic steatosis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003
Abscess limb	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0012 events1 affected2 at risk EG0020 events0 affected73 at risk EG003
Angular cheilitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0012 events1 affected2 at risk EG0020 events0 affected73 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0011 events1 affected2 at risk EG0020 events0 affected73 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0012 events1 affected2 at risk EG0021 events1 affected73 at risk EG003
Hot flush	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0012 events1 affected2 at risk EG0020 events0 affected73 at risk EG003
Thrombosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected73 at risk EG003

ID	Term
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Luspatercept 0.5 mg/kg	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).	0	1	1	1	0	1
EG001	Luspatercept 0.75 mg/kg	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).	0	2	1	2	1	2
EG002	Luspatercept 1 mg/kg	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).	4	73	19	73	44	73
EG003	Luspatercept 1.33 mg/kg	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).	3	61	16	61	29	61
EG004	Luspatercept 1.75 mg/kg	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).	6	49	34	49	38	49