NCT03682536 · OUTCOME

Overall Survival (OS)

A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve · Source last updated 2024-11-20

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

Measure: MEDIAN
Unit: Months
Interval / dispersion: 95% Confidence Interval
Time frame: Randomization to death due to any cause up to 5 years from first dose or 3 years from last dose (whichever occurs later), unless the participant withdraws consent from the study, dies or is lost to follow-up. (Up to approximately 221 weeks)

What was measured

Time from date of randomization to death due to any cause

Analysis population: ITT Population - all randomized participants regardless of whether or not the participant received treatment.

Groups in this outcome

Luspatercept

Starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks (21 days; Q3W). Dose levels can be increased in a stepwise manner beyond the starting dose to 1.33 mg/kg, and up to a maximum of 1.75 mg/kg.

Epoetin Alfa

Starting dose of 450 IU/kg (maximum total starting dose is 40,000 IU) subcutaneous injection once every week (7 days; QW). Dose levels can be increased in a stepwise manner beyond the starting dose to 787.5 IU/kg, and up to a maximum of 1,050 IU/kg (with a maximum total dose of 80,000 IU).

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	182
Epoetin Alfa	181

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	NA	Not reported	35.3	NA	Insufficient number of participants with events
Epoetin Alfa	42.8	Not reported	42.8	NA	Insufficient number of participants with events

Complete source fields

classes

categories
measurements
comment
Insufficient number of participants with events
group Id
OG000
lower Limit
35.3
upper Limit
NA
value
NA
comment
Insufficient number of participants with events
group Id
OG001
lower Limit
42.8
upper Limit
NA
value
42.8

denoms

counts
group Id
OG000
value
182
group Id
OG001
value
181
units
Participants

description

Time from date of randomization to death due to any cause

dispersion Type

95% Confidence Interval

groups

description
Starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks (21 days; Q3W). Dose levels can be increased in a stepwise manner beyond the starting dose to 1.33 mg/kg, and up to a maximum of 1.75 mg/kg.
id
OG000
title
Luspatercept
description
Starting dose of 450 IU/kg (maximum total starting dose is 40,000 IU) subcutaneous injection once every week (7 days; QW). Dose levels can be increased in a stepwise manner beyond the starting dose to 787.5 IU/kg, and up to a maximum of 1,050 IU/kg (with a maximum total dose of 80,000 IU).
id
OG001
title
Epoetin Alfa

param Type

MEDIAN

population Description

ITT Population - all randomized participants regardless of whether or not the participant received treatment.

reporting Status

POSTED

time Frame

Randomization to death due to any cause up to 5 years from first dose or 3 years from last dose (whichever occurs later), unless the participant withdraws consent from the study, dies or is lost to follow-up. (Up to approximately 221 weeks)

title

Overall Survival (OS)

type

SECONDARY

unit Of Measure

Months

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

Preserved source evidence · Not medical advice