NCT02631070 · OUTCOME

Percentage of Participants Who Progressed to Acute Myeloid Leukemia (AML)

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: NUMBER
Unit: Percentage of Participants
Interval / dispersion: Not reported
Time frame: From randomization to study completion (up to approximately 57 months)

What was measured

Percentage of participants progressing to AML throughout the course of the study

Analysis population: All treated participants

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	76

Reported measurements

Source class 1

Values in Percentage of Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Luspatercept	2.6	Not reported	Not reported	Not reported	Not reported
Placebo	3.9	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
2.6
group Id
OG001
value
3.9

denoms

counts
group Id
OG000
value
153
group Id
OG001
value
76
units
Participants

description

Percentage of participants progressing to AML throughout the course of the study

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

NUMBER

population Description

All treated participants

reporting Status

POSTED

time Frame

From randomization to study completion (up to approximately 57 months)

title

Percentage of Participants Who Progressed to Acute Myeloid Leukemia (AML)

type

SECONDARY

unit Of Measure

Percentage of Participants

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

Preserved source evidence · Not medical advice