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NCT02604433 · OUTCOME

Number of Days Spent in Higher Care Hospital Units

An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Adults Who Require Regular Red Blood Cell Transfusions Due to Beta (β) Thalassemia · Source last updated 2023-04-18

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 informed consent signing (up to 12 weeks before start of treatment) to end of treatment (up to approximately 227 weeks)

What was measured

Types of hospitals units considered to be 'higher care' are: - Intensive Care Unit - Coronary Care Unit

Analysis population: All randomized participants who spent time in higher care hospital units

Groups in this outcome

Luspatercept + BSC

Luspatercept (ACE-536) was administered subcutaneously (SC) at a starting dose level of 1 mg/kg once every 21 days. Participants could be dose-titrated to 1.25 mg/kg, but the maximum total dose should not exceed 120 mg, total dose per administration during the Treatment Period, the Long-term Treatment Period, and Open-Label Treatment Period. BSC = Best Supportive Care

Placebo + BSC

Placebo (normal saline) was administered subcutaneously (SC) in volumes to match active treatment once every 21 days. BSC = Best Supportive Care

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

Analysis denominator · Participants

GroupSource count
Luspatercept + BSC43
Placebo + BSC5

Reported measurements

Source class 1
Values in Days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Luspatercept + BSC8.023.70Not reportedNot reportedNot reported
Placebo + BSC0.60.55Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.70
        value
        8.0
      2. group Id
        OG001
        spread
        0.55
        value
        0.6
denoms
  1. counts
    1. group Id
      OG000
      value
      43
    2. group Id
      OG001
      value
      5
    units
    Participants
description
Types of hospitals units considered to be 'higher care' are: - Intensive Care Unit - Coronary Care Unit
dispersion Type
Standard Deviation
groups
  1. description
    Luspatercept (ACE-536) was administered subcutaneously (SC) at a starting dose level of 1 mg/kg once every 21 days. Participants could be dose-titrated to 1.25 mg/kg, but the maximum total dose should not exceed 120 mg, total dose per administration during the Treatment Period, the Long-term Treatment Period, and Open-Label Treatment Period. BSC = Best Supportive Care
    id
    OG000
    title
    Luspatercept + BSC
  2. description
    Placebo (normal saline) was administered subcutaneously (SC) in volumes to match active treatment once every 21 days. BSC = Best Supportive Care
    id
    OG001
    title
    Placebo + BSC
param Type
MEAN
population Description
All randomized participants who spent time in higher care hospital units
reporting Status
POSTED
time Frame
From informed consent signing (up to 12 weeks before start of treatment) to end of treatment (up to approximately 227 weeks)
title
Number of Days Spent in Higher Care Hospital Units
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice