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NCT01190644 · OUTCOME

Change From Baseline in Plasma Volume Following a Single Dose of Sotatercept

Study to Evaluate Effect of a Single Dose of Sotatercept (ACE-011) on Red Blood Cell Mass and Plasma Volume in Participants With Solid Tumors · Source last updated 2023-11-29

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

Measure
MEAN
Unit
mL
Interval / dispersion
Standard Deviation
Time frame
Baseline (Day 1, pre-dose) and one timepoint between Day 14 and Day 28

What was measured

Blood samples were collected at baseline (Day 1, pre-dose) and at one timepoint between Day 14 and Day 28, and isotope dilution techniques used, to measure the change from baseline in plasma volume following a single dose of sotatercept.

Analysis population: All participants who received at least one dose of study treatment and had data for Change from Baseline in Plasma Volume Following a Single Dose of Sotatercept

Groups in this outcome

Sotatercept

Participants received a single 35 mg dose of sotatercept by SC injection on Day 1, Day 43, and Day 85.

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

Analysis denominator · Participants

GroupSource count
Sotatercept2

Reported measurements

Source class 1
Values in mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sotatercept-239.50219.91Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        219.91
        value
        -239.50
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    units
    Participants
description
Blood samples were collected at baseline (Day 1, pre-dose) and at one timepoint between Day 14 and Day 28, and isotope dilution techniques used, to measure the change from baseline in plasma volume following a single dose of sotatercept.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received a single 35 mg dose of sotatercept by SC injection on Day 1, Day 43, and Day 85.
    id
    OG000
    title
    Sotatercept
param Type
MEAN
population Description
All participants who received at least one dose of study treatment and had data for Change from Baseline in Plasma Volume Following a Single Dose of Sotatercept
reporting Status
POSTED
time Frame
Baseline (Day 1, pre-dose) and one timepoint between Day 14 and Day 28
title
Change From Baseline in Plasma Volume Following a Single Dose of Sotatercept
type
SECONDARY
unit Of Measure
mL

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

Preserved source evidence · Not medical advice