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NCT01794520 · OUTCOME

Phase 2: Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score

Study Evaluating ABT-199 in Participants With Relapsed or Refractory Multiple Myeloma · Source last updated 2023-04-10

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

Measure
MEAN
Unit
T-score
Interval / dispersion
Standard Deviation
Time frame
Baseline; Cycle 3, Day 1; Cycle 5, Day 1; Cycle 7, Day 1; Cycle 9, Day 1; Cycle 11, Day 1; Cycle 13, Day 1; Cycle 15, Day 1; Cycle 17, Day 1; Cycle 19, Day 1; Cycle 21, Day 1; Cycle 23, Day 1; Cycle 25, Day 1; Final visit

What was measured

PROMIS Cancer Fatigue SF is a seven item questionnaire that assesses the impact and experience of fatigue over the past 7 days. All questions employ the following five response options: 1 = Not at all, 2 = A little bit, 3 = Somewhat, 4 = Quite a bit, and 5 = Very much. The total raw score is the sum of the responses to each question and is converted to a T-score. The T-score re-scales the total raw score to a standardized score with a mean of 50 and a standard deviation of 10. The \[PROMIS\] Cancer Fatigue Short Form \[SF\] 7a T-Scores range from 29.4 to 83.2, with higher scores indicating more fatigue. Negative changes from baseline indicate improvement.

Analysis population: Intent-to-Treat (ITT) population: all participants who received at least one dose of study drug; participants who have both baseline and post-baseline values are included in the analysis at each visit

Groups in this outcome

Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg

The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).

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

Analysis denominator · Participants

GroupSource count
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg16

Reported measurements

Cycle 3, Day 1

Analysis denominator · Participants

GroupSource count
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg16
Values in T-score · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg0.65.88Not reportedNot reportedNot reported
Cycle 5, Day 1

Analysis denominator · Participants

GroupSource count
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg10
Values in T-score · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg-2.95.30Not reportedNot reportedNot reported
Cycle 7, Day 1

Analysis denominator · Participants

GroupSource count
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg8
Values in T-score · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg-1.84.21Not reportedNot reportedNot reported
Cycle 9, Day 1

Analysis denominator · Participants

GroupSource count
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg8
Values in T-score · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg-1.64.85Not reportedNot reportedNot reported
Cycle 11, Day 1

Analysis denominator · Participants

GroupSource count
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg7
Values in T-score · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg0.17.24Not reportedNot reportedNot reported
Cycle 13, Day 1

Analysis denominator · Participants

GroupSource count
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg7
Values in T-score · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg1.04.54Not reportedNot reportedNot reported
Cycle 15, Day 1

Analysis denominator · Participants

GroupSource count
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg7
Values in T-score · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg-3.45.69Not reportedNot reportedNot reported
Cycle 17, Day 1

Analysis denominator · Participants

GroupSource count
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg6
Values in T-score · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg0.67.36Not reportedNot reportedNot reported
Cycle 19, Day 1

Analysis denominator · Participants

GroupSource count
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg3
Values in T-score · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg6.62.25Not reportedNot reportedNot reported
Cycle 21, Day 1

Analysis denominator · Participants

GroupSource count
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg2
Values in T-score · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg11.66.51Not reportedNot reportedNot reported
Cycle 23, Day 1

Analysis denominator · Participants

GroupSource count
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg2
Values in T-score · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg6.00.57Not reportedNot reportedNot reported
Cycle 25, Day 1

Analysis denominator · Participants

GroupSource count
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg1
Values in T-score · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg5.6Not reportedNot reportedNot reportedNot reported
Final visit

Analysis denominator · Participants

GroupSource count
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg16
Values in T-score · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg1.46.51Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.88
        value
        0.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      units
      Participants
    title
    Cycle 3, Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.30
        value
        -2.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      units
      Participants
    title
    Cycle 5, Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.21
        value
        -1.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    Cycle 7, Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.85
        value
        -1.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    Cycle 9, Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.24
        value
        0.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      units
      Participants
    title
    Cycle 11, Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.54
        value
        1.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      units
      Participants
    title
    Cycle 13, Day 1
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.69
        value
        -3.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      units
      Participants
    title
    Cycle 15, Day 1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.36
        value
        0.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      units
      Participants
    title
    Cycle 17, Day 1
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.25
        value
        6.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    Cycle 19, Day 1
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.51
        value
        11.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    Cycle 21, Day 1
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.57
        value
        6.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    Cycle 23, Day 1
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        5.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Cycle 25, Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    units
    Participants
description
PROMIS Cancer Fatigue SF is a seven item questionnaire that assesses the impact and experience of fatigue over the past 7 days. All questions employ the following five response options: 1 = Not at all, 2 = A little bit, 3 = Somewhat, 4 = Quite a bit, and 5 = Very much. The total raw score is the sum of the responses to each question and is converted to a T-score. The T-score re-scales the total raw score to a standardized score with a mean of 50 and a standard deviation of 10. The \[PROMIS\] Cancer Fatigue Short Form \[SF\] 7a T-Scores range from 29.4 to 83.2, with higher scores indicating more fatigue. Negative changes from baseline indicate improvement.
dispersion Type
Standard Deviation
groups
  1. description
    The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
    id
    OG000
    title
    Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
param Type
MEAN
population Description
Intent-to-Treat (ITT) population: all participants who received at least one dose of study drug; participants who have both baseline and post-baseline values are included in the analysis at each visit
reporting Status
POSTED
time Frame
Baseline; Cycle 3, Day 1; Cycle 5, Day 1; Cycle 7, Day 1; Cycle 9, Day 1; Cycle 11, Day 1; Cycle 13, Day 1; Cycle 15, Day 1; Cycle 17, Day 1; Cycle 19, Day 1; Cycle 21, Day 1; Cycle 23, Day 1; Cycle 25, Day 1; Final visit
title
Phase 2: Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score
type
SECONDARY
unit Of Measure
T-score

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice