NCT02631070 · OUTCOME

Pharmacokinetic (PK) Parameters: Bayesian Estimate of Apparent Volume of Distribution of the Central Compartment (V1/F)

A Study of Luspatercept (ACE-536) to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes · Source last updated 2021-12-17

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

Measure: GEOMETRIC_MEAN
Unit: L
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Blood serum samples taken pre-dose at Cycle 1 Day 1 (C1, D1), C1 D8, C1 D15, C2 D1, C4 D1, C5 D8, C6 D1 and Week 25 visit, extension phase C4 D1 and Day 1 of every fourth treatment cycle thereafter.

What was measured

Apparent volume of distribution of luspatercept was calculated according to the equation Vz = (CL)/λ.

Analysis population: Pharmacokinetic population included all participants who received at least 1 dose of luspatercept and had measurable luspatercept serum concentrations.

Groups in this outcome

Luspatercept

Luspatercept 1.0 mg/Kg SC on Day 1 of each 21-day treatment cycle

Placebo

Placebo (Volume equivalent to experimental arm) SC on Day 1 of each 21-day treatment cycle

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

Analysis denominator · Participants

Group	Source count
Luspatercept	153
Placebo	0

Reported measurements

Source class 1

Values in L · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	9.68	26.5	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
26.5
value
9.68

denoms

counts
group Id
OG000
value
153
group Id
OG001
value
0
units
Participants

description

Apparent volume of distribution of luspatercept was calculated according to the equation Vz = (CL)/λ.

dispersion Type

Geometric Coefficient of Variation

groups

description
Luspatercept 1.0 mg/Kg SC on Day 1 of each 21-day treatment cycle
id
OG000
title
Luspatercept
description
Placebo (Volume equivalent to experimental arm) SC on Day 1 of each 21-day treatment cycle
id
OG001
title
Placebo

param Type

GEOMETRIC_MEAN

population Description

Pharmacokinetic population included all participants who received at least 1 dose of luspatercept and had measurable luspatercept serum concentrations.

reporting Status

POSTED

time Frame

Blood serum samples taken pre-dose at Cycle 1 Day 1 (C1, D1), C1 D8, C1 D15, C2 D1, C4 D1, C5 D8, C6 D1 and Week 25 visit, extension phase C4 D1 and Day 1 of every fourth treatment cycle thereafter.

title

Pharmacokinetic (PK) Parameters: Bayesian Estimate of Apparent Volume of Distribution of the Central Compartment (V1/F)

type

SECONDARY

unit Of Measure

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice