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NCT02604433 · OUTCOME

Participants With Treatment-Emergent Adverse Events (TEAE)

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 first dose to 90 days following last dose (up to approximately 52 months)

What was measured

An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. A serious AE is any AE occurring at any dose that - Results in death - Is life-threatening - Requires or prolongs existing inpatient hospitalization - Results in persistent or significant disability/incapacity - Is a congenital anomaly/birth defect - Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.03): - Grade 1 = Mild - Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention) - Grade 3 = Severe (limitation in activity; medical intervention required) - Grade 4 = Life-threatening - Grade 5 = Death

Analysis population: All treated 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 + BSC223
Placebo + BSC109

Reported measurements

≥ 1 Treatment-emergent adverse event (TEAE)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Luspatercept + BSC219Not reportedNot reportedNot reportedNot reported
Placebo + BSC102Not reportedNot reportedNot reportedNot reported
Serious TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Luspatercept + BSC53Not reportedNot reportedNot reportedNot reported
Placebo + BSC8Not reportedNot reportedNot reportedNot reported
Grade ≥ 3 TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Luspatercept + BSC84Not reportedNot reportedNot reportedNot reported
Placebo + BSC19Not reportedNot reportedNot reportedNot reported
Treatment-related TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Luspatercept + BSC135Not reportedNot reportedNot reportedNot reported
Placebo + BSC31Not reportedNot reportedNot reportedNot reported
Treatment-related Serious TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Luspatercept + BSC13Not reportedNot reportedNot reportedNot reported
Placebo + BSC0Not reportedNot reportedNot reportedNot reported
Treatment-related TEAE ≥ Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Luspatercept + BSC27Not reportedNot reportedNot reportedNot reported
Placebo + BSC1Not reportedNot reportedNot reportedNot reported
TEAE leading to death
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Luspatercept + BSC2Not reportedNot reportedNot reportedNot reported
Placebo + BSC1Not reportedNot reportedNot reportedNot reported
Trt-related TEAE leading to death
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Luspatercept + BSC0Not reportedNot reportedNot reportedNot reported
Placebo + BSC0Not reportedNot reportedNot reportedNot reported
TEAE leading to dose reduction
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Luspatercept + BSC10Not reportedNot reportedNot reportedNot reported
Placebo + BSC3Not reportedNot reportedNot reportedNot reported
TEAE leading to dose delay
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Luspatercept + BSC46Not reportedNot reportedNot reportedNot reported
Placebo + BSC11Not reportedNot reportedNot reportedNot reported
TEAE leading to drug discontinuation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Luspatercept + BSC25Not reportedNot reportedNot reportedNot reported
Placebo + BSC2Not reportedNot reportedNot reportedNot reported
Trt-related TEAE leading to dose reduction
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Luspatercept + BSC9Not reportedNot reportedNot reportedNot reported
Placebo + BSC2Not reportedNot reportedNot reportedNot reported
Trt-related TEAE leading to dose delay
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Luspatercept + BSC15Not reportedNot reportedNot reportedNot reported
Placebo + BSC3Not reportedNot reportedNot reportedNot reported
Trt-related TEAE leading to drug discontinuation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Luspatercept + BSC20Not reportedNot reportedNot reportedNot reported
Placebo + BSC1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        219
      2. group Id
        OG001
        value
        102
    title
    ≥ 1 Treatment-emergent adverse event (TEAE)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        53
      2. group Id
        OG001
        value
        8
    title
    Serious TEAE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        84
      2. group Id
        OG001
        value
        19
    title
    Grade ≥ 3 TEAE
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        135
      2. group Id
        OG001
        value
        31
    title
    Treatment-related TEAE
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        0
    title
    Treatment-related Serious TEAE
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        1
    title
    Treatment-related TEAE ≥ Grade 3
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
    title
    TEAE leading to death
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Trt-related TEAE leading to death
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        3
    title
    TEAE leading to dose reduction
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        46
      2. group Id
        OG001
        value
        11
    title
    TEAE leading to dose delay
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        2
    title
    TEAE leading to drug discontinuation
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        2
    title
    Trt-related TEAE leading to dose reduction
denoms
  1. counts
    1. group Id
      OG000
      value
      223
    2. group Id
      OG001
      value
      109
    units
    Participants
description
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. A serious AE is any AE occurring at any dose that - Results in death - Is life-threatening - Requires or prolongs existing inpatient hospitalization - Results in persistent or significant disability/incapacity - Is a congenital anomaly/birth defect - Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.03): - Grade 1 = Mild - Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention) - Grade 3 = Severe (limitation in activity; medical intervention required) - Grade 4 = Life-threatening - Grade 5 = Death
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 treated participants
reporting Status
POSTED
time Frame
From first dose to 90 days following last dose (up to approximately 52 months)
title
Participants With Treatment-Emergent Adverse Events (TEAE)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice