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NCT03361748 · OUTCOME

Mean Change From Baseline on the EORTC QLQ-MY20 - Side Effects

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-MY20 The EORTC has developed a myeloma module referred to as QLQ- MY20, to be administered alongside the core QLQ-C30. The QLQ-MY20 is a 20-item myeloma module intended for use among patients varying in disease stage and treatment modality. All items will be scored from 0 to 100. The average of the scores will represent the symptoms score. A high score for a symptom scale/item represents a high level of symptomatic problem.

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
BB21212.59.51Not reportedNot reportedNot reported
Month 1

Analysis denominator · Participants

GroupSource count
BB2121109
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
BB21210.011.95Not reportedNot reportedNot reported
Month 3

Analysis denominator · Participants

GroupSource count
BB212186
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
BB2121-2.611.45Not reportedNot reportedNot reported
Month 6

Analysis denominator · Participants

GroupSource count
BB212175
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
BB2121-4.710.16Not reportedNot reportedNot reported
Month 9

Analysis denominator · Participants

GroupSource count
BB212158
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
BB2121-6.510.28Not reportedNot reportedNot reported
Month 12

Analysis denominator · Participants

GroupSource count
BB212155
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
BB2121-4.011.87Not reportedNot reportedNot reported
Month 18

Analysis denominator · Participants

GroupSource count
BB212126
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
BB2121-3.49.96Not reportedNot reportedNot reported
Month 24

Analysis denominator · Participants

GroupSource count
BB212114
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
BB2121-3.27.98Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.51
        value
        2.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        114
      units
      Participants
    title
    Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.95
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        109
      units
      Participants
    title
    Month 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.45
        value
        -2.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        86
      units
      Participants
    title
    Month 3
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.16
        value
        -4.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        75
      units
      Participants
    title
    Month 6
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.28
        value
        -6.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        58
      units
      Participants
    title
    Month 9
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.87
        value
        -4.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        55
      units
      Participants
    title
    Month 12
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.96
        value
        -3.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      units
      Participants
    title
    Month 18
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.98
        value
        -3.2
    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-MY20 The EORTC has developed a myeloma module referred to as QLQ- MY20, to be administered alongside the core QLQ-C30. The QLQ-MY20 is a 20-item myeloma module intended for use among patients varying in disease stage and treatment modality. All items will be scored from 0 to 100. The average of the scores will represent the symptoms score. A high score for a symptom scale/item represents a high level of symptomatic problem.
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-MY20 - Side Effects
type
SECONDARY
unit Of Measure
Score on a Scale

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

Preserved source evidence · Not medical advice