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NCT03361748 · OUTCOME

Mean Change From Baseline on the EORTC QLQ-C30 - Fatigue.

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 European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) The QLQ-C30 employs a week recall period for all items. 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
BB21214.418.56Not reportedNot reportedNot reported
Month 1

Analysis denominator · Participants

GroupSource count
BB2121109
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
BB21211.124.38Not reportedNot reportedNot reported
Month 3

Analysis denominator · Participants

GroupSource count
BB212186
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
BB2121-10.124.32Not reportedNot reportedNot reported
Month 6

Analysis denominator · Participants

GroupSource count
BB212176
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
BB2121-15.124.39Not reportedNot reportedNot reported
Month 9

Analysis denominator · Participants

GroupSource count
BB212159
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
BB2121-21.524.58Not reportedNot reportedNot reported
Month 12

Analysis denominator · Participants

GroupSource count
BB212155
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
BB2121-16.425.02Not reportedNot reportedNot reported
Month 18

Analysis denominator · Participants

GroupSource count
BB212126
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
BB2121-18.419.10Not reportedNot reportedNot reported
Month 24

Analysis denominator · Participants

GroupSource count
BB212114
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
BB2121-7.915.97Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.56
        value
        4.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        114
      units
      Participants
    title
    Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.38
        value
        1.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        109
      units
      Participants
    title
    Month 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.32
        value
        -10.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        86
      units
      Participants
    title
    Month 3
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.39
        value
        -15.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        76
      units
      Participants
    title
    Month 6
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.58
        value
        -21.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      units
      Participants
    title
    Month 9
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.02
        value
        -16.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        55
      units
      Participants
    title
    Month 12
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.10
        value
        -18.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      units
      Participants
    title
    Month 18
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.97
        value
        -7.9
    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 European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) The QLQ-C30 employs a week recall period for all items. 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-C30 - Fatigue.
type
SECONDARY
unit Of Measure
Score on a Scale

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

Preserved source evidence · Not medical advice