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NCT01794520 · OUTCOME

Phase 2: Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain

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
units on a scale
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

The BPI-SF is a pain-specific measure developed to assess patient-reported severity (or intensity) of pain (4 items) and the impact of pain on daily functioning (7 items) in patients with cancer pain. The four pain severity items assess pain at its "worst in last 24 hours," "least in last 24 hours," "average," and "now" (current pain). For these items, participants are asked to rate their pain on an 11-point numeric rating scale with anchors of 0 (no pain) and 10 (pain as bad as you can imagine). The Worst Pain scores range from 0 to 10, with higher scores indicating severe pain. 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 units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg0.22.47Not 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 units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg-0.91.43Not 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 units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg-0.91.20Not 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 units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg-0.91.46Not 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 units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg-1.11.62Not 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 units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg0.53.84Not 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 units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg-0.61.27Not 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 units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg-1.61.29Not 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 units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg-1.82.00Not 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 units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg-1.62.30Not 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 units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg-1.62.30Not 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 units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg-3.8Not reportedNot reportedNot reportedNot reported
Final visit

Analysis denominator · Participants

GroupSource count
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg16
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg-0.31.86Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.47
        value
        0.2
    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
        1.43
        value
        -0.9
    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
        1.20
        value
        -0.9
    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
        1.46
        value
        -0.9
    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
        1.62
        value
        -1.1
    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
        3.84
        value
        0.5
    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
        1.27
        value
        -0.6
    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
        1.29
        value
        -1.6
    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
        2.00
        value
        -1.8
    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
        2.30
        value
        -1.6
    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
        2.30
        value
        -1.6
    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
        -3.8
    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
The BPI-SF is a pain-specific measure developed to assess patient-reported severity (or intensity) of pain (4 items) and the impact of pain on daily functioning (7 items) in patients with cancer pain. The four pain severity items assess pain at its "worst in last 24 hours," "least in last 24 hours," "average," and "now" (current pain). For these items, participants are asked to rate their pain on an 11-point numeric rating scale with anchors of 0 (no pain) and 10 (pain as bad as you can imagine). The Worst Pain scores range from 0 to 10, with higher scores indicating severe pain. 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 Brief Pain Inventory - Short Form (BPI-SF) Worst Pain
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice