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NCT05546476 · BASELINE

Baseline characteristics

Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15 · Source last updated 2026-06-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      45
    2. group Id
      BG001
      value
      46
    3. group Id
      BG002
      value
      46
    4. group Id
      BG003
      value
      50
    5. group Id
      BG004
      value
      187
    units
    Participants
groups
  1. description
    Part A: Participants were randomized to receive placebo matching to Ponsegromab SC Q4W up to 12 weeks (total of 3 doses). Part B: On completion of Part A, participants had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year.
    id
    BG000
    title
    Part A: Placebo/ Part B: Ponsegromab 400 mg
  2. description
    Part A: Participants were randomized to receive Ponsegromab 100 mg SC Q4W up to 12 weeks (total of 3 doses). Part B: On completion of Part A, participants had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year.
    id
    BG001
    title
    Part A: Ponsegromab 100 mg/ Part B: Ponsegromab 400 mg
  3. description
    Part A: Participants were randomized to receive Ponsegromab 200 mg SC Q4W up to 12 weeks (total of 3 doses). Part B: On completion of Part A, participants had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year.
    id
    BG002
    title
    Part A: Ponsegromab 200 mg/ Part B: Ponsegromab 400 mg
  4. description
    Part A: Participants were randomized to receive Ponsegromab 400 mg SC Q4W up to 12 weeks (total of 3 doses). Part B: On completion of Part A, participants had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year.
    id
    BG003
    title
    Part A: Ponsegromab 400 mg/ Part B: Ponsegromab 400 mg
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.26
          value
          63.2
        2. group Id
          BG001
          spread
          9.38
          value
          70.1
        3. group Id
          BG002
          spread
          9.61
          value
          65.9
        4. group Id
          BG003
          spread
          9.93
          value
          66.1
        5. group Id
          BG004
          spread
          10.28
          value
          66.4
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          69
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          31
        4. group Id
          BG003
          value
          32
        5. group Id
          BG004
          value
          118
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          9
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          44
        4. group Id
          BG003
          value
          43
        5. group Id
          BG004
          value
          172
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          6
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          70
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          35
        5. group Id
          BG004
          value
          116
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      45
    2. group Id
      BG001
      value
      46
    3. group Id
      BG002
      value
      46
    4. group Id
      BG003
      value
      50
    5. group Id
      BG004
      value
      187
    units
    Participants
groups
  1. description
    Part A: Participants were randomized to receive placebo matching to Ponsegromab SC Q4W up to 12 weeks (total of 3 doses). Part B: On completion of Part A, participants had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year.
    id
    BG000
    title
    Part A: Placebo/ Part B: Ponsegromab 400 mg
  2. description
    Part A: Participants were randomized to receive Ponsegromab 100 mg SC Q4W up to 12 weeks (total of 3 doses). Part B: On completion of Part A, participants had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year.
    id
    BG001
    title
    Part A: Ponsegromab 100 mg/ Part B: Ponsegromab 400 mg
  3. description
    Part A: Participants were randomized to receive Ponsegromab 200 mg SC Q4W up to 12 weeks (total of 3 doses). Part B: On completion of Part A, participants had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year.
    id
    BG002
    title
    Part A: Ponsegromab 200 mg/ Part B: Ponsegromab 400 mg
  4. description
    Part A: Participants were randomized to receive Ponsegromab 400 mg SC Q4W up to 12 weeks (total of 3 doses). Part B: On completion of Part A, participants had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year.
    id
    BG003
    title
    Part A: Ponsegromab 400 mg/ Part B: Ponsegromab 400 mg
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.26
          value
          63.2
        2. group Id
          BG001
          spread
          9.38
          value
          70.1
        3. group Id
          BG002
          spread
          9.61
          value
          65.9
        4. group Id
          BG003
          spread
          9.93
          value
          66.1
        5. group Id
          BG004
          spread
          10.28
          value
          66.4
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          69
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          31
        4. group Id
          BG003
          value
          32
        5. group Id
          BG004
          value
          118
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          9
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          44
        4. group Id
          BG003
          value
          43
        5. group Id
          BG004
          value
          172
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          6
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          70
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          35
        5. group Id
          BG004
          value
          116
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice