NCT02631070 · OUTCOME

Time to Red Blood Cell Transfusion Independence (RBC-TI) - Week 1 Through Week 24

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: MEAN
Unit: Days
Interval / dispersion: Standard Deviation
Time frame: From first dose to Week 24 of study treatment

What was measured

Time to RBC-TI was defined as the time between first dose date and the date of onset of RBC-TI first observed for participants who achieved RBC-TI of ≥ 8 weeks during Week 1 through Week 24

Analysis population: All participants who achieved RBC-TI ≥ 8 weeks during Week 1 through Week 24

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	58
Placebo	10

Reported measurements

Source class 1

Values in Days · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	17.2	29.40	Not reported	Not reported	Not reported
Placebo	26.0	31.83	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
29.40
value
17.2
group Id
OG001
spread
31.83
value
26.0

denoms

counts
group Id
OG000
value
58
group Id
OG001
value
10
units
Participants

description

Time to RBC-TI was defined as the time between first dose date and the date of onset of RBC-TI first observed for participants who achieved RBC-TI of ≥ 8 weeks during Week 1 through Week 24

dispersion Type

Standard Deviation

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

MEAN

population Description

All participants who achieved RBC-TI ≥ 8 weeks during Week 1 through Week 24

reporting Status

POSTED

time Frame

From first dose to Week 24 of study treatment

title

Time to Red Blood Cell Transfusion Independence (RBC-TI) - Week 1 Through Week 24

type

SECONDARY

unit Of Measure

Days

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

Preserved source evidence · Not medical advice