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NCT03361748 · OUTCOME

Mean Change From Baseline on the EORTC QLQ-C30 - Global Heath/QoL

Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma · Source last updated 2025-05-23

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

Measure
MEAN
Unit
Score on a Scale
Interval / dispersion
Standard Deviation
Time frame
At Day 1 and at specific time points up to month 24

What was measured

Mean change from baseline on the EORTC QLQ-C30 The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures. All of the scales and single-item measures range in score from 0 to 100. A higher scale score represents a higher level of well-being and better ability of daily functioning. Thus, a high score for a functional scale represents a high/healthy level of functioning; a high score for the global health status/HRQoL represents a high HRQoL.

Analysis population: PRO Analysis Set

Groups in this outcome

BB2121

BB2121

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

Analysis denominator · Participants

GroupSource count
BB2121126

Reported measurements

Day 1

Analysis denominator · Participants

GroupSource count
BB2121114
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
BB2121-4.717.03Not reportedNot reportedNot reported
Month 1

Analysis denominator · Participants

GroupSource count
BB2121109
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
BB21214.319.95Not reportedNot reportedNot reported
Month 3

Analysis denominator · Participants

GroupSource count
BB212186
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
BB21218.820.31Not reportedNot reportedNot reported
Month 6

Analysis denominator · Participants

GroupSource count
BB212176
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
BB212112.519.12Not reportedNot reportedNot reported
Month 9

Analysis denominator · Participants

GroupSource count
BB212159
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
BB212115.720.88Not reportedNot reportedNot reported
Month 12

Analysis denominator · Participants

GroupSource count
BB212155
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
BB212114.121.57Not reportedNot reportedNot reported
Month 18

Analysis denominator · Participants

GroupSource count
BB212126
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
BB212110.617.25Not reportedNot reportedNot reported
Month 24

Analysis denominator · Participants

GroupSource count
BB212114
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
BB21217.114.93Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.03
        value
        -4.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        114
      units
      Participants
    title
    Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.95
        value
        4.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        109
      units
      Participants
    title
    Month 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.31
        value
        8.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        86
      units
      Participants
    title
    Month 3
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.12
        value
        12.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        76
      units
      Participants
    title
    Month 6
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.88
        value
        15.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      units
      Participants
    title
    Month 9
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.57
        value
        14.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        55
      units
      Participants
    title
    Month 12
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.25
        value
        10.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      units
      Participants
    title
    Month 18
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.93
        value
        7.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      units
      Participants
    title
    Month 24
denoms
  1. counts
    1. group Id
      OG000
      value
      126
    units
    Participants
description
Mean change from baseline on the EORTC QLQ-C30 The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures. All of the scales and single-item measures range in score from 0 to 100. A higher scale score represents a higher level of well-being and better ability of daily functioning. Thus, a high score for a functional scale represents a high/healthy level of functioning; a high score for the global health status/HRQoL represents a high HRQoL.
dispersion Type
Standard Deviation
groups
  1. description
    BB2121
    id
    OG000
    title
    BB2121
param Type
MEAN
population Description
PRO Analysis Set
reporting Status
POSTED
time Frame
At Day 1 and at specific time points up to month 24
title
Mean Change From Baseline on the EORTC QLQ-C30 - Global Heath/QoL
type
SECONDARY
unit Of Measure
Score on a Scale

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

Preserved source evidence · Not medical advice