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NCT02604433 · OUTCOME

Number of Participants Who Utilized Healthcare Resources During Study

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
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

Number of participants who had any of the following types of Healthcare Resource Utilization (HRU): - a doctor office visit (non-study scheduled) - an emergency department visit - a hospitalization

Analysis population: All randomized participants

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 + BSC224
Placebo + BSC112

Reported measurements

Doctor Office Visit
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Luspatercept + BSC186Not reportedNot reportedNot reportedNot reported
Placebo + BSC69Not reportedNot reportedNot reportedNot reported
Emergency Department Visit
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Luspatercept + BSC71Not reportedNot reportedNot reportedNot reported
Placebo + BSC22Not reportedNot reportedNot reportedNot reported
Hospital Admission
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Luspatercept + BSC61Not reportedNot reportedNot reportedNot reported
Placebo + BSC5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        186
      2. group Id
        OG001
        value
        69
    title
    Doctor Office Visit
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        71
      2. group Id
        OG001
        value
        22
    title
    Emergency Department Visit
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        61
      2. group Id
        OG001
        value
        5
    title
    Hospital Admission
denoms
  1. counts
    1. group Id
      OG000
      value
      224
    2. group Id
      OG001
      value
      112
    units
    Participants
description
Number of participants who had any of the following types of Healthcare Resource Utilization (HRU): - a doctor office visit (non-study scheduled) - an emergency department visit - a hospitalization
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
COUNT_OF_PARTICIPANTS
population Description
All randomized participants
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 Participants Who Utilized Healthcare Resources During Study
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice