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NCT05546476 · OUTCOME

Part A: Number of Participants With Post-Baseline Vital Signs Meeting the Predefined Criteria

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Day 1 up to Week 12

What was measured

Vital signs criteria included: supine systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg), increase and decrease in change of more than or equal to (\>=) 30mmHg; supine diastolic blood pressure (DBP) \<50 mmHg, increase and decrease in change of \>= 20mmHg; pulse rate \<40 beats per minute (bpm) to \>120 bpm. Only rows which included at least 1 participant in any reporting group with abnormality were reported in this outcome measure.

Analysis population: 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. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Groups in this outcome

Part A: Placebo

Part A: Participants were randomized to receive placebo matching to Ponsegromab SC Q4W up to 12 weeks (total of 3 doses).

Part A: Ponsegromab 100 mg

Part A: Participants were randomized to receive Ponsegromab 100 mg SC Q4W up to 12 weeks (total of 3 doses).

Part A: Ponsegromab 200 mg

Part A: Participants were randomized to receive Ponsegromab 200 mg SC Q4W up to 12 weeks (total of 3 doses).

Part A: Ponsegromab 400 mg

Part A: Participants were randomized to receive Ponsegromab 400 mg SC Q4W up to 12 weeks (total of 3 doses).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part A: Placebo40
Part A: Ponsegromab 100 mg40
Part A: Ponsegromab 200 mg44
Part A: Ponsegromab 400 mg44

Reported measurements

Supine SBP Value < 90mmHg
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Placebo0Not reportedNot reportedNot reportedNot reported
Part A: Ponsegromab 100 mg3Not reportedNot reportedNot reportedNot reported
Part A: Ponsegromab 200 mg0Not reportedNot reportedNot reportedNot reported
Part A: Ponsegromab 400 mg0Not reportedNot reportedNot reportedNot reported
Supine SBP Increase Change >= 30mmHg
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Placebo4Not reportedNot reportedNot reportedNot reported
Part A: Ponsegromab 100 mg5Not reportedNot reportedNot reportedNot reported
Part A: Ponsegromab 200 mg8Not reportedNot reportedNot reportedNot reported
Part A: Ponsegromab 400 mg2Not reportedNot reportedNot reportedNot reported
Supine SBP Decrease Change >= 30mmHg
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Placebo2Not reportedNot reportedNot reportedNot reported
Part A: Ponsegromab 100 mg6Not reportedNot reportedNot reportedNot reported
Part A: Ponsegromab 200 mg5Not reportedNot reportedNot reportedNot reported
Part A: Ponsegromab 400 mg4Not reportedNot reportedNot reportedNot reported
Supine DBP Value < 50mmHg
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Placebo0Not reportedNot reportedNot reportedNot reported
Part A: Ponsegromab 100 mg1Not reportedNot reportedNot reportedNot reported
Part A: Ponsegromab 200 mg0Not reportedNot reportedNot reportedNot reported
Part A: Ponsegromab 400 mg0Not reportedNot reportedNot reportedNot reported
Supine SBP Increase Change >= 20mmHg
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Placebo4Not reportedNot reportedNot reportedNot reported
Part A: Ponsegromab 100 mg4Not reportedNot reportedNot reportedNot reported
Part A: Ponsegromab 200 mg3Not reportedNot reportedNot reportedNot reported
Part A: Ponsegromab 400 mg4Not reportedNot reportedNot reportedNot reported
Supine DBP Decrease Change >= 20mmHg
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Placebo3Not reportedNot reportedNot reportedNot reported
Part A: Ponsegromab 100 mg4Not reportedNot reportedNot reportedNot reported
Part A: Ponsegromab 200 mg4Not reportedNot reportedNot reportedNot reported
Part A: Ponsegromab 400 mg3Not reportedNot reportedNot reportedNot reported
Supine Pulse Rate Value > 120mmHg
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Placebo0Not reportedNot reportedNot reportedNot reported
Part A: Ponsegromab 100 mg1Not reportedNot reportedNot reportedNot reported
Part A: Ponsegromab 200 mg3Not reportedNot reportedNot reportedNot reported
Part A: Ponsegromab 400 mg1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Supine SBP Value < 90mmHg
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        2
    title
    Supine SBP Increase Change >= 30mmHg
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        4
    title
    Supine SBP Decrease Change >= 30mmHg
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Supine DBP Value < 50mmHg
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        4
    title
    Supine SBP Increase Change >= 20mmHg
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        3
    title
    Supine DBP Decrease Change >= 20mmHg
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        1
    title
    Supine Pulse Rate Value > 120mmHg
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    2. group Id
      OG001
      value
      40
    3. group Id
      OG002
      value
      44
    4. group Id
      OG003
      value
      44
    units
    Participants
description
Vital signs criteria included: supine systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg), increase and decrease in change of more than or equal to (\>=) 30mmHg; supine diastolic blood pressure (DBP) \<50 mmHg, increase and decrease in change of \>= 20mmHg; pulse rate \<40 beats per minute (bpm) to \>120 bpm. Only rows which included at least 1 participant in any reporting group with abnormality were reported in this outcome measure.
groups
  1. description
    Part A: Participants were randomized to receive placebo matching to Ponsegromab SC Q4W up to 12 weeks (total of 3 doses).
    id
    OG000
    title
    Part A: Placebo
  2. description
    Part A: Participants were randomized to receive Ponsegromab 100 mg SC Q4W up to 12 weeks (total of 3 doses).
    id
    OG001
    title
    Part A: Ponsegromab 100 mg
  3. description
    Part A: Participants were randomized to receive Ponsegromab 200 mg SC Q4W up to 12 weeks (total of 3 doses).
    id
    OG002
    title
    Part A: Ponsegromab 200 mg
  4. description
    Part A: Participants were randomized to receive Ponsegromab 400 mg SC Q4W up to 12 weeks (total of 3 doses).
    id
    OG003
    title
    Part A: Ponsegromab 400 mg
param Type
COUNT_OF_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. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Day 1 up to Week 12
title
Part A: Number of Participants With Post-Baseline Vital Signs Meeting the Predefined Criteria
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice