Study of Sotatercept for the Treatment of Chemotherapy In... | NCT00931606 | Trialant
NCT00931606
Sponsor
Merck Sharp & Dohme LLC
Status
Terminated
Last Update Posted
Sep 13, 2023Actual
Enrollment
30Actual
Phase
Phase 2
Conditions
Chemotherapy Induced Anemia
Interventions
Sotatercept
Placebo
Countries
United States
Russia
Protocol Section
Identification Module
NCT ID
NCT00931606
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
7962-012
Secondary IDs
ID
Type
Description
Link
A011-08
Other Identifier
Acceleron pharma
MK-7962-012
Other Identifier
Merck
Brief Title
Study of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer (MK-7962-012)
Official Title
A Phase 2, Double-blind, Randomized, Placebo-Controlled Study of ACE-011 for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Aug 2023
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
administrative reasons (slow patient enrollment)
Expanded Access Info
No
Start Date
Jun 1, 2009Actual
Primary Completion Date
Nov 18, 2010Actual
Completion Date
Nov 18, 2010Actual
First Submitted Date
May 22, 2009
First Submission Date that Met QC Criteria
Jul 1, 2009
First Posted Date
Jul 2, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
May 22, 2023
Results First Submitted that Met QC Criteria
Aug 21, 2023
Results First Posted Date
Sep 13, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Nov 14, 2017
Certification/Extension First Submitted that Passed QC Review
Nov 14, 2017
Certification/Extension First Posted Date
Nov 17, 2017Actual
Last Update Submitted Date
Aug 21, 2023
Last Update Posted Date
Sep 13, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the percentage of participants in each sotatercept dose regimen who achieve a hematopoietic response during the treatment period including up to 2 months after the last dose of sotatercept treatment of chemotherapy-induced anemia (CIA) in participants with metastatic breast cancer. Hematopoietic response was defined as an increase in hemoglobin concentration of ≥ 1 g/dL relative to baseline for 28 consecutive days during the treatment period including up to 2 months after the last dose of sotatercept in the absence of red blood cell (RBC) transfusion or treatment with an erythropoiesis-stimulating agent (ESA).
Detailed Description
Not provided
Conditions Module
Conditions
Chemotherapy Induced Anemia
Keywords
anemia
metastatic
breast
cancer
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
30Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Sotatercept 0.1 mg/kg
Experimental
Participants will receive sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.
Biological: Sotatercept
Sotatercept 0.3 mg/kg
Experimental
Participants will receive sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.
Biological: Sotatercept
Sotatercept 0.5 mg/kg
Experimental
Participants will receive sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Biological: Sotatercept
Placebo
Placebo Comparator
Participants will receive placebo subcutaneously every 28 days up to 4 doses.
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Sotatercept
Biological
up to 4 subcutaneous doses of sotatercept given once every 28 days
Sotatercept 0.1 mg/kg
Sotatercept 0.3 mg/kg
Sotatercept 0.5 mg/kg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Achieved a Hematopoietic Response
Hematopoietic response rate is defined as the percentage of participants who had increase in hemoglobin concentration of ≥ 1 g/dL relative to baseline for 28 consecutive days during the treatment period including up to 2 months after the last dose of study treatment in the absence of red blood cell (RBC) transfusion or treatment with an erythropoiesis-stimulating agent (ESA). The percentage of participants who achieved hematopoietic response is presented.
Baseline and Up to ~145 Days
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants Who Experienced an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced AEs is reported.
Up to ~175 Days
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Has a histologically confirmed diagnosis of breast cancer documented by cytology or biopsy.
Has evidence of metastatic breast cancer with a minimum of one lesion per Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST v 1.1) criteria.
Is receiving a chemotherapy regimen including one of the following: anthracycline, taxane, gemcitabine, vinorelbine or capecitabine.
Has planned treatment with the same chemotherapy regimen for a minimum of 9 weeks after Day 1 of study intervention administration.
≥ 30 days elapsed (from Day 1) since previous treatment with an erythropoiesis stimulating agent (ESA) (including treatment with intravenous (IV) iron) for chemotherapy induced anemia.
≥ 7 days elapsed (from Day 1) since the last red blood cell (RBC) transfusion and receipt of ≤ 2 units of blood in the past 30 days.
Life expectancy of ≥ 6 months.
Exclusion Criteria:
Has had prior radiation therapy to > 20% of the whole skeleton.
Has had > 5 prior chemotherapy treatment regimens for metastatic breast cancer.
Has a history of autoimmune or hereditary hemolysis or gastrointestinal bleeding.
Has clinically significant pulmonary, endocrine, neurologic, gastrointestinal, hepatic or genitourinary disease unrelated to underlying hematologic disorder.
Has heart failure as classified by the New York Heart Association (NYHA) classification of 3 or higher.
Has a recent history of thrombosis, deep vein thrombosis (DVT), pulmonary emboli, or embolic stroke, occurring within the last 6 months.
Has untreated central nervous system (CNS) metastases or CNS metastases treated with whole brain radiotherapy < 6 months prior to Day 1.
Has a diagnosis of a myeloid malignancy or known history of myelodysplasia.
Has a history of second malignancy within 5 years (except excised and cured basal cell carcinoma, squamous cell carcinoma of the skin or cervical carcinoma in situ).
Has had administration of IV antibiotics or febrile (temperature elevation > 38 ° C) within 14 days of Day 1.
Has uncontrolled hypertension.
Has known history of hepatitis B surface antigen (HBsAg and HB core antibody (Ab)), human immunodeficiency virus (HIV) antibody or active hepatitis C.
Has clinically significant iron (transferrin saturation < 20%), vitamin B12, or folate deficiency.
Has a history of anemia as a result of inherited hemoglobinopathy such as sickle cell anemia or thalassemia.
Has a history of autoimmune or hereditary hemolysis; active gastrointestinal bleeding (within the last 6 months as compared to Day 1).
Has received treatment with another investigational drug or device within 1 month prior to Day 1.
Is pregnant or lactating.
Has a history of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational product.
Has had major surgery within 30 days prior to Day 1 (patients must have completely recovered from any previous surgery prior to Day 1).
Raftopoulos H, Laadem A, Hesketh PJ, Goldschmidt J, Gabrail N, Osborne C, Ali M, Sherman ML, Wang D, Glaspy JA, Puccio-Pick M, Zou J, Crawford J. Sotatercept (ACE-011) for the treatment of chemotherapy-induced anemia in patients with metastatic breast cancer or advanced or metastatic solid tumors treated with platinum-based chemotherapeutic regimens: results from two phase 2 studies. Support Care Cancer. 2016 Apr;24(4):1517-25. doi: 10.1007/s00520-015-2929-9. Epub 2015 Sep 14.
This study was terminated early after 30 participants were enrolled due to slower than expected rate of enrollment as a result of changes in guidance for the treatment of participants with breast cancer and chemotherapy induced anemia (CIA).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Sotatercept 0.1 mg/kg
Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.
FG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.
up to 4 subcutaneous doses of placebo given once every 28 days
Placebo
Number of Participants Who Discontinued Study Intervention Due to an Adverse Event
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants discontinuing study intervention due to AEs is reported.
Up to ~85 Days
Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥ 2 g/dL
Percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL for 28 consecutive days during the treatment period and up to 2 months after the last dose of study treatment in the absence of RBC transfusion or treatment with an ESA. The percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL for 28 consecutive days is presented.
Baseline and Up to ~145 Days
Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL
Percentage of participants achieving hemoglobin ≥ 11 g/dL for 28 consecutive days during the treatment period and up to 2 months after the last dose of study treatment in the absence of RBC transfusion or treatment with an ESA. The percentage of participants achieving an increase from baseline hemoglobin of ≥ 11 g/dL for 28 consecutive days is presented.
Baseline and Up to ~145 Days
Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥2 g/dL and/or Hemoglobin ≥ 11 g/dL
Percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL and/or hemoglobin ≥ 11 g/dL for 28 consecutive days during the treatment period and up to 2 months after the last dose of study treatment in the absence of RBC transfusion or treatment with an ESA. The percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL and/or hemoglobin ≥ 11 g/dL for 28 consecutive days is presented.
Baseline and Up to ~145 Days
Duration of Hematopoietic Response for Hemoglobin ≥ 1 g/dL
Duration of hematopoietic response is defined as the time period from the first time hemoglobin increases at least ≥ 1 g/dL from baseline to the last time there is hemoglobin ≥ 1 g/dL increase from baseline. Duration of response is only calculated for a responder and will be at least 28 days. The duration of response is only calculated for a patient who meets the primary efficacy endpoint. The data for duration of response for ≥ 1 g/dL from baseline is presented.
Baseline and Up to ~145 Days
Duration of Hematopoietic Response for Hemoglobin ≥ 2 g/dL
Duration of hematopoietic response is defined as the time period from the first time hemoglobin increases at least ≥ 2 g/dL from baseline to the last time there is hemoglobin ≥ 2 g/dL increase from baseline. Duration of response is only calculated for a responder and will be at least 28 days. The duration of response is only calculated for a patient who meets the primary efficacy endpoint. The data for duration of response for hemoglobin ≥ 2 g/dL from baseline is presented.
Baseline and Up to ~145 Days
Duration of Hematopoietic Response for Hemoglobin ≥ 11 g/dL
Duration of hematopoietic response is defined as the time period from the first time hemoglobin increases at least ≥ 11 g/dL from baseline to the last time there is hemoglobin ≥ 11 g/dL increase from baseline. Duration of response is only calculated for a responder and will be at least 28 days. The duration of response is only calculated for a patient who meets the primary efficacy endpoint. The data for duration of response for hemoglobin ≥ 11 g/dL from baseline is presented.
Baseline and Up to ~145 Days
Duration of Hematopoietic Response for Hemoglobin Increases ≥ 1 g/dL and/or Hemoglobin Concentration ≥ 11 g/dL
Duration of hematopoietic response is defined as the time period the first time hemoglobin increases ≥ 1 g/dL and/or hemoglobin concentration is ≥ 11 g/dL from baseline to the last time when the same response is maintained. The data for duration of response for hemoglobin ≥ 1 g/dL and/or hemoglobin concentration ≥ 11 g/dL from baseline is presented.
Baseline and Up to ~145 Days
Duration of Hematopoietic Response for Hemoglobin Increases ≥ 2 g/dL, and/or Hemoglobin Concentration ≥ 11 g/dL
Duration of hematopoietic response is defined as the time period the first time hemoglobin increases ≥ 2 g/dL, and/or hemoglobin concentration is ≥ 11 g/dL from baseline to the last time when the same response is maintained. The data for duration of response for hemoglobin ≥ 2 g/dL and/or hemoglobin concentration ≥ 11 g/dL from baseline is presented.
Baseline and Up to ~145 Days
Time to Achieve Hematopoietic Response of Hemoglobin ≥ 1 g/dL Increase From Baseline
Time to achieve hematopoietic response based on ≥ 1 g/dL increase from baseline, is defined as the time from first dose of study treatment to the first hemoglobin increase ≥ 1 g/dL that was maintained for at least 28 consecutive days. The data for time to achieve hematopoietic response for hemoglobin ≥ 1 g/dL from baseline is presented.
Baseline and Up to ~145 Days
Time to Achieve Hematopoietic Response of Hemoglobin ≥ 2 g/dL Increase From Baseline
Time to achieve hematopoietic response based on ≥ 2 g/dL increase from baseline, is defined as the time from first dose of study treatment to the first hemoglobin increase ≥ 2 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin ≥ 2 g/dL from baseline is presented.
Baseline and Up to ~145 Days
Time to Achieve Hematopoietic Response of Hemoglobin ≥ 11 g/dL From Baseline
Time to achieve hematopoietic response based on hemoglobin ≥ 11 g/dL, defined as the time from first dose of study treatment to the first hemoglobin ≥ 11 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin ≥ 11 g/dL from baseline is presented.
Baseline and Up to ~145 Days
Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 1 g/dL and/or Hemoglobin ≥ 11 g/dL
Time to achieve hematopoietic response based on multiple criteria categories, defined as the time from first dose of study treatment to first hemoglobin increase ≥ 1 g/dL and/or hemoglobin ≥ 11 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin increase from baseline ≥ 1 g/dL and/or ≥ 11 g/dL from baseline is presented.
Baseline and Up to ~145 Days
Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 2 g/dL and/or Hemoglobin ≥ 11 g/dL
Time to achieve hematopoietic response, defined as the time from first dose of study treatment to first hemoglobin increase ≥ 2 g/dL and/or hemoglobin ≥ 11 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin increase from baseline ≥ 2 g/dL and/or ≥ 11 g/dL from baseline is presented.
Baseline and Up to ~145 Days
Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA
The percentage of participants who received RBC transfusion or treatment with an ESA in each study treatment group as well as within each cycle of each study treatment is presented.
Up to Day 141
Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1).
ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR at Day 64 is presented.
Baseline and Day 64
Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1.
ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR of non-target lesions at Day 64 is presented.
Day 64
Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1.
ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR at Day 113 is presented.
Day 113
Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1.
ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR of non-target lesions at Day 113 is presented.
Day 113
Progression-free Survival (PFS)
PFS was defined as the time from start of the chemotherapy regimen (which could have occurred prior to study start and collected as prior anticancer therapy) to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 is presented.
From start of chemotherapy (which could have occurred prior to study start) up to Study Day 281
Hot Springs
Arkansas
United States
Investigative Site
Beverly Hills
California
United States
Investigative Site
Corona
California
United States
Investigative Site
Fountain Valley
California
United States
Investigative Site
Montebello
California
United States
Investigative Site
Riverside
California
United States
Investigative Site
Denver
Colorado
United States
Investigative Site
Boynton Beach
Florida
United States
Investigative Site
Hinsdale
Illinois
United States
Investigative Site
Evansville
Indiana
United States
Investigative Site
Wichita
Kansas
United States
Investigative Site
Baltimore
Maryland
United States
Investigative Site
Grand Rapids
Michigan
United States
Investigative Site
Tupelo
Mississippi
United States
Investigative Site
Kansas City
Missouri
United States
Investigative Site
Nyack
New York
United States
Investigative Site
Goldsboro
North Carolina
United States
Investigative Site
High Point
North Carolina
United States
Investigative Site
Winston-Salem
North Carolina
United States
Investigative Site
Bismarck
North Dakota
United States
Investigative Site
Middletown
Ohio
United States
Investigative Site
Philadelphia
Pennsylvania
United States
Investigative Site
Charleston
South Carolina
United States
Investigative Site
Austin
Texas
United States
Investigative Site
Dallas
Texas
United States
Investigative Site
Tyler
Texas
United States
Investigative Site
Lacey
Washington
United States
Investigative Site
Krasnodar
Russia
Investigative Site
Moscow
Russia
Investigative Site
Nizhny Novgorod
Russia
Investigative Site
Nizhny Novograd (2)
Russia
Investigative Site
Pyatigorsk
Russia
Investigative Site
Saint Petersburg
Russia
Investigative Site
Stavropol
Russia
FG002
Sotatercept 0.5 mg/kg
Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
FG003
Placebo
Participants received placebo subcutaneously every 28 days up to 4 doses.
FG0008 subjects
FG00110 subjects
FG0027 subjects
FG0035 subjects
COMPLETED
FG0003 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
NOT COMPLETED
FG0005 subjects
FG0019 subjects
FG0026 subjects
FG0033 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0013 subjects
FG0022 subjects
FG0030 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
Sponsor Decision
FG0001 subjects
FG0014 subjects
FG0020 subjects
FG0032 subjects
Withdrawal by Subject
FG0003 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Sotatercept 0.1 mg/kg
Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.
BG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.
BG002
Sotatercept 0.5 mg/kg
Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
BG003
Placebo
Participants received placebo subcutaneously every 28 days up to 4 doses.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0008
BG00110
BG0027
BG0035
BG00430
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00051.6± 9.38
BG00150.8± 8.51
BG00255.6± 12.53
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0008
BG00110
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Weight
Participants weight in kilograms is presented as the mean for each treatment arm.
Mean
Standard Deviation
Kilograms
Title
Denominators
Categories
Title
Measurements
BG00067.38± 18.338
BG00171.80± 9.500
Chemotherapy Frequency
Chemotherapy frequency among the Modified Intent to Treat Group was differentiated as either weekly or less frequently for participants.
Count of Participants
Participants
Title
Denominators
Categories
Weekly
Title
Measurements
BG0002
BG0012
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
Percentage of Participants Who Achieved a Hematopoietic Response
Hematopoietic response rate is defined as the percentage of participants who had increase in hemoglobin concentration of ≥ 1 g/dL relative to baseline for 28 consecutive days during the treatment period including up to 2 months after the last dose of study treatment in the absence of red blood cell (RBC) transfusion or treatment with an erythropoiesis-stimulating agent (ESA). The percentage of participants who achieved hematopoietic response is presented.
All randomized participants who have confirmed CIA, received at least one dose of study intervention and on study intervention for at least 2 months (57 days).
Posted
Number
95% Confidence Interval
Percentage of Participants
Baseline and Up to ~145 Days
ID
Title
Description
OG000
Sotatercept 0.1 mg/kg
Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.
OG002
Sotatercept 0.5 mg/kg
Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
OG003
Placebo
Participants received placebo subcutaneously every 28 days up to 4 doses.
OG004
All Sotatercept-treated Participants
Participants received sotatercept at one of the following doses: 0.1 mg/kg, 0.3 mg/kg, or 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Units
Counts
Participants
OG0005
OG0019
OG0024
OG003
Title
Denominators
Categories
Overall
ParticipantsOG0005
ParticipantsOG0019
ParticipantsOG0024
ParticipantsOG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Overall
Fisher Exact
Clopper and Pearson exact approach
>0.999
P-values greater than 0.999 are reported as ">0.999".
Superiority
OG001
OG003
Overall
Secondary
Number of Participants Who Experienced an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced AEs is reported.
All participants who received at least one dose of study intervention.
Posted
Count of Participants
Participants
Up to ~175 Days
ID
Title
Description
OG000
Sotatercept 0.1 mg/kg
Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.
OG002
Sotatercept 0.5 mg/kg
Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
OG003
Placebo
Participants received placebo subcutaneously every 28 days up to 4 doses.
Secondary
Number of Participants Who Discontinued Study Intervention Due to an Adverse Event
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants discontinuing study intervention due to AEs is reported.
All participants who received at least one dose of study intervention.
Posted
Count of Participants
Participants
Up to ~85 Days
ID
Title
Description
OG000
Sotatercept 0.1 mg/kg
Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.
OG002
Sotatercept 0.5 mg/kg
Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
OG003
Placebo
Participants received placebo subcutaneously every 28 days up to 4 doses.
Secondary
Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥ 2 g/dL
Percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL for 28 consecutive days during the treatment period and up to 2 months after the last dose of study treatment in the absence of RBC transfusion or treatment with an ESA. The percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL for 28 consecutive days is presented.
All randomized participants who have confirmed CIA, received at least one dose of study intervention and on study treatment for at least 2 months (57 days).
Posted
Number
95% Confidence Interval
Percentage of Participants
Baseline and Up to ~145 Days
ID
Title
Description
OG000
Sotatercept 0.1 mg/kg
Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.
OG002
Sotatercept 0.5 mg/kg
Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Secondary
Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL
Percentage of participants achieving hemoglobin ≥ 11 g/dL for 28 consecutive days during the treatment period and up to 2 months after the last dose of study treatment in the absence of RBC transfusion or treatment with an ESA. The percentage of participants achieving an increase from baseline hemoglobin of ≥ 11 g/dL for 28 consecutive days is presented.
All randomized participants who have confirmed CIA, received at least one dose of study intervention and on study intervention for at least 2 months (57 days).
Posted
Number
95% Confidence Interval
Percentage of Participants
Baseline and Up to ~145 Days
ID
Title
Description
OG000
Sotatercept 0.1 mg/kg
Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.
OG002
Sotatercept 0.5 mg/kg
Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
OG003
Secondary
Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥2 g/dL and/or Hemoglobin ≥ 11 g/dL
Percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL and/or hemoglobin ≥ 11 g/dL for 28 consecutive days during the treatment period and up to 2 months after the last dose of study treatment in the absence of RBC transfusion or treatment with an ESA. The percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL and/or hemoglobin ≥ 11 g/dL for 28 consecutive days is presented.
All randomized participants who have confirmed CIA, received at least one dose of study intervention and on study intervention for at least 2 months (57 days).
Posted
Number
95% Confidence Interval
Percentage of Participants
Baseline and Up to ~145 Days
ID
Title
Description
OG000
Sotatercept 0.1 mg/kg
Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.
OG002
Sotatercept 0.5 mg/kg
Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Secondary
Duration of Hematopoietic Response for Hemoglobin ≥ 1 g/dL
Duration of hematopoietic response is defined as the time period from the first time hemoglobin increases at least ≥ 1 g/dL from baseline to the last time there is hemoglobin ≥ 1 g/dL increase from baseline. Duration of response is only calculated for a responder and will be at least 28 days. The duration of response is only calculated for a patient who meets the primary efficacy endpoint. The data for duration of response for ≥ 1 g/dL from baseline is presented.
All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥1 g/dL and less than 2 g/dL increase from baseline.
Posted
Mean
Standard Deviation
Days
Baseline and Up to ~145 Days
ID
Title
Description
OG000
Sotatercept 0.1 mg/kg
Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.
OG002
Sotatercept 0.5 mg/kg
Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Secondary
Duration of Hematopoietic Response for Hemoglobin ≥ 2 g/dL
Duration of hematopoietic response is defined as the time period from the first time hemoglobin increases at least ≥ 2 g/dL from baseline to the last time there is hemoglobin ≥ 2 g/dL increase from baseline. Duration of response is only calculated for a responder and will be at least 28 days. The duration of response is only calculated for a patient who meets the primary efficacy endpoint. The data for duration of response for hemoglobin ≥ 2 g/dL from baseline is presented.
All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥2 g/dL and less than 11 g/dL increase from baseline.
Posted
Mean
Standard Deviation
Days
Baseline and Up to ~145 Days
ID
Title
Description
OG000
Sotatercept 0.1 mg/kg
Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.
OG002
Sotatercept 0.5 mg/kg
Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Secondary
Duration of Hematopoietic Response for Hemoglobin ≥ 11 g/dL
Duration of hematopoietic response is defined as the time period from the first time hemoglobin increases at least ≥ 11 g/dL from baseline to the last time there is hemoglobin ≥ 11 g/dL increase from baseline. Duration of response is only calculated for a responder and will be at least 28 days. The duration of response is only calculated for a patient who meets the primary efficacy endpoint. The data for duration of response for hemoglobin ≥ 11 g/dL from baseline is presented.
All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days), and had a hematopoietic response of ≥11 g/dL increase from baseline.
Posted
Mean
Standard Deviation
Days
Baseline and Up to ~145 Days
ID
Title
Description
OG000
Sotatercept 0.1 mg/kg
Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.
OG002
Sotatercept 0.5 mg/kg
Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Secondary
Duration of Hematopoietic Response for Hemoglobin Increases ≥ 1 g/dL and/or Hemoglobin Concentration ≥ 11 g/dL
Duration of hematopoietic response is defined as the time period the first time hemoglobin increases ≥ 1 g/dL and/or hemoglobin concentration is ≥ 11 g/dL from baseline to the last time when the same response is maintained. The data for duration of response for hemoglobin ≥ 1 g/dL and/or hemoglobin concentration ≥ 11 g/dL from baseline is presented.
All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days), and had a hematopoietic response of ≥ 1 g/dL and/or hemoglobin concentration is ≥11 g/dL increase from baseline.
Posted
Mean
Standard Deviation
Days
Baseline and Up to ~145 Days
ID
Title
Description
OG000
Sotatercept 0.1 mg/kg
Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.
OG002
Sotatercept 0.5 mg/kg
Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Secondary
Duration of Hematopoietic Response for Hemoglobin Increases ≥ 2 g/dL, and/or Hemoglobin Concentration ≥ 11 g/dL
Duration of hematopoietic response is defined as the time period the first time hemoglobin increases ≥ 2 g/dL, and/or hemoglobin concentration is ≥ 11 g/dL from baseline to the last time when the same response is maintained. The data for duration of response for hemoglobin ≥ 2 g/dL and/or hemoglobin concentration ≥ 11 g/dL from baseline is presented.
All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥ 2 g/dL and/or hemoglobin concentration is ≥11 g/dL increase from baseline.
Posted
Mean
Standard Deviation
Days
Baseline and Up to ~145 Days
ID
Title
Description
OG000
Sotatercept 0.1 mg/kg
Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.
OG002
Sotatercept 0.5 mg/kg
Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Secondary
Time to Achieve Hematopoietic Response of Hemoglobin ≥ 1 g/dL Increase From Baseline
Time to achieve hematopoietic response based on ≥ 1 g/dL increase from baseline, is defined as the time from first dose of study treatment to the first hemoglobin increase ≥ 1 g/dL that was maintained for at least 28 consecutive days. The data for time to achieve hematopoietic response for hemoglobin ≥ 1 g/dL from baseline is presented.
All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥ 1 g/dL increase from baseline.
Posted
Median
95% Confidence Interval
Days
Baseline and Up to ~145 Days
ID
Title
Description
OG000
Sotatercept 0.1 mg/kg
Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.
OG002
Sotatercept 0.5 mg/kg
Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Secondary
Time to Achieve Hematopoietic Response of Hemoglobin ≥ 2 g/dL Increase From Baseline
Time to achieve hematopoietic response based on ≥ 2 g/dL increase from baseline, is defined as the time from first dose of study treatment to the first hemoglobin increase ≥ 2 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin ≥ 2 g/dL from baseline is presented.
All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥ 2 g/dL increase from baseline.
Posted
Median
95% Confidence Interval
Days
Baseline and Up to ~145 Days
ID
Title
Description
OG000
Sotatercept 0.1 mg/kg
Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.
OG002
Sotatercept 0.5 mg/kg
Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
OG003
Secondary
Time to Achieve Hematopoietic Response of Hemoglobin ≥ 11 g/dL From Baseline
Time to achieve hematopoietic response based on hemoglobin ≥ 11 g/dL, defined as the time from first dose of study treatment to the first hemoglobin ≥ 11 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin ≥ 11 g/dL from baseline is presented.
All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had hematopoietic response of ≥ 11 g/dL increase from baseline.
Posted
Median
95% Confidence Interval
Days
Baseline and Up to ~145 Days
ID
Title
Description
OG000
Sotatercept 0.1 mg/kg
Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.
OG002
Sotatercept 0.5 mg/kg
Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
OG003
Secondary
Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 1 g/dL and/or Hemoglobin ≥ 11 g/dL
Time to achieve hematopoietic response based on multiple criteria categories, defined as the time from first dose of study treatment to first hemoglobin increase ≥ 1 g/dL and/or hemoglobin ≥ 11 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin increase from baseline ≥ 1 g/dL and/or ≥ 11 g/dL from baseline is presented.
All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥ 1 g/dL and/or hemoglobin concentration is ≥11 g/dL increase from baseline.
Posted
Median
95% Confidence Interval
Days
Baseline and Up to ~145 Days
ID
Title
Description
OG000
Sotatercept 0.1 mg/kg
Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.
OG002
Sotatercept 0.5 mg/kg
Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Secondary
Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 2 g/dL and/or Hemoglobin ≥ 11 g/dL
Time to achieve hematopoietic response, defined as the time from first dose of study treatment to first hemoglobin increase ≥ 2 g/dL and/or hemoglobin ≥ 11 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin increase from baseline ≥ 2 g/dL and/or ≥ 11 g/dL from baseline is presented.
All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥ 2 g/dL and/or hemoglobin concentration is ≥11 g/dL increase from baseline.
Posted
Median
95% Confidence Interval
Days
Baseline and Up to ~145 Days
ID
Title
Description
OG000
Sotatercept 0.1 mg/kg
Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.
OG002
Sotatercept 0.5 mg/kg
Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Secondary
Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA
The percentage of participants who received RBC transfusion or treatment with an ESA in each study treatment group as well as within each cycle of each study treatment is presented.
All randomized participants who have confirmed CIA, received at least one dose of study intervention and on study intervention for at least 2 months (57 days).
Posted
Number
Percentage of Participants
Up to Day 141
ID
Title
Description
OG000
Sotatercept 0.1 mg/kg
Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.
OG002
Sotatercept 0.5 mg/kg
Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
OG003
Placebo
Participants received placebo subcutaneously every 28 days up to 4 doses.
Secondary
Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1).
ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR at Day 64 is presented.
All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a response.
Posted
Number
Percentage of Participants
Baseline and Day 64
ID
Title
Description
OG000
Sotatercept 0.1 mg/kg
Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.
OG002
Sotatercept 0.5 mg/kg
Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
OG003
Secondary
Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1.
ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR of non-target lesions at Day 64 is presented.
All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a response.
Posted
Number
Percentage of Participants
Day 64
ID
Title
Description
OG000
Sotatercept 0.1 mg/kg
Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.
OG002
Sotatercept 0.5 mg/kg
Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
OG003
Placebo
Secondary
Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1.
ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR at Day 113 is presented.
All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a response.
Posted
Number
Percentage of Participants
Day 113
ID
Title
Description
OG000
Sotatercept 0.1 mg/kg
Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.
OG002
Sotatercept 0.5 mg/kg
Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
OG003
Placebo
Secondary
Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1.
ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR of non-target lesions at Day 113 is presented.
All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a response.
Posted
Number
Percentage of Participants
Day 113
ID
Title
Description
OG000
Sotatercept 0.1 mg/kg
Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.
OG002
Sotatercept 0.5 mg/kg
Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
OG003
Placebo
Secondary
Progression-free Survival (PFS)
PFS was defined as the time from start of the chemotherapy regimen (which could have occurred prior to study start and collected as prior anticancer therapy) to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 is presented.
All randomized participants who received at least one dose of study intervention.
Posted
Median
95% Confidence Interval
Days
From start of chemotherapy (which could have occurred prior to study start) up to Study Day 281
ID
Title
Description
OG000
Sotatercept 0.1 mg/kg
Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.
OG002
Sotatercept 0.5 mg/kg
Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Time Frame
Up to Day 281
Description
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Sotatercept 0.1 mg/kg
Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.
1
8
0
8
6
8
EG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.
3
10
2
10
7
10
EG002
Sotatercept 0.5 mg/kg
Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
3
7
3
7
7
7
EG003
Placebo
Participants received placebo subcutaneously every 28 days up to 4 doses.
0
5
1
5
5
5
EG004
Total
Total for all participants
7
30
6
30
25
30
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected30 at risk
Gastric ulcer perforation
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0022 events2 affected7 at risk
EG003
Peptic ulcer
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0022 events2 affected7 at risk
EG003
Asthenia
General disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Fatigue
General disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Anorexia
Metabolism and nutrition disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Breast cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Syncope
Nervous system disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Hypotension
Vascular disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 11.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0013 events3 affected10 at risk
EG0022 events2 affected7 at risk
EG0031 events1 affected5 at risk
EG0047 events7 affected30 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 11.1
Systematic Assessment
EG0008 events3 affected8 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 11.1
Systematic Assessment
EG0009 events4 affected8 at risk
EG0010 events0 affected10 at risk
EG0023 events2 affected7 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 11.1
Systematic Assessment
EG0003 events2 affected8 at risk
EG0011 events1 affected10 at risk
EG0026 events1 affected7 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Nodal arrhythmia
Cardiac disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0012 events2 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0025 events2 affected7 at risk
EG003
Oral discomfort
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Peritoneal effusion
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Pneumoperitoneum
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected10 at risk
EG0024 events3 affected7 at risk
EG003
Asthenia
General disorders
MedDRA 11.1
Systematic Assessment
EG0003 events3 affected8 at risk
EG0012 events2 affected10 at risk
EG0024 events2 affected7 at risk
EG003
Chest pain
General disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Fatigue
General disorders
MedDRA 11.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected10 at risk
EG0022 events2 affected7 at risk
EG003
Generalised oedema
General disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Hyperthermia
General disorders
MedDRA 11.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Influenza like illness
General disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Local swelling
General disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Oedema peripheral
General disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0022 events2 affected7 at risk
EG003
Pain
General disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Pyrexia
General disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Liver disorder
Hepatobiliary disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Clostridial infection
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Helicobacter infection
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Paronychia
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Streptococcal infection
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Device migration
Injury, poisoning and procedural complications
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Blood albumin decreased
Investigations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0022 events2 affected7 at risk
EG003
Prothrombin time prolonged
Investigations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Skin turgor decreased
Investigations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Staphylococcal identification test positive
Investigations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Urine output decreased
Investigations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Vitamin D decreased
Investigations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Weight decreased
Investigations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Anorexia
Metabolism and nutrition disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0012 events1 affected10 at risk
EG0022 events2 affected7 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0022 events2 affected7 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0022 events2 affected7 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0012 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0015 events2 affected10 at risk
EG0022 events2 affected7 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Muscle haemorrhage
Musculoskeletal and connective tissue disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0012 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0013 events3 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0012 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Metastases to gastrointestinal tract
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Metastases to lymph nodes
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Coma
Nervous system disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Convulsion
Nervous system disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0012 events2 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Dyskinesia
Nervous system disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Headache
Nervous system disorders
MedDRA 11.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected10 at risk
EG0022 events2 affected7 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Hypersomnia
Nervous system disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 11.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Unresponsive to stimuli
Nervous system disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Enuresis
Renal and urinary disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Polyuria
Renal and urinary disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Breast mass
Reproductive system and breast disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0012 events1 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 11.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0022 events2 affected7 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 11.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0012 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA 11.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected7 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0012 events2 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Flushing
Vascular disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Hypertension
Vascular disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected7 at risk
EG003
Hypotension
Vascular disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0022 events2 affected7 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected7 at risk
EG003
This is an acquired study. No restrictions were imposed on time on current chemotherapy prior to study entry, therefore PFS could have gone beyond the study duration. The time from start of current chemotherapy could have occurred prior to study start and collected as prior anticancer therapy, therefore the upper limit of the confidence interval in the "Sotatercept 0.5 mg/kg" arm, "1791.0 days", didn't exceed the timeframe of 281 days after study start.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
All information concerning Sotatercept is considered confidential and shall remain the sole property of the Sponsor. No publication or disclosure of study results will be permitted except as specified in a separate, written, agreement between the Sponsor and the Investigator.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development