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NCT01308580 · OUTCOME

Change From Baseline in FACT-P:Total Score as a Measure of HRQoL

Cabazitaxel at 20 mg/m² Compared to 25 mg/m² With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer · Source last updated 2017-04-17

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

Measure
LEAST_SQUARES_MEAN
Unit
units on a scale
Interval / dispersion
95% Confidence Interval
Time frame
Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks)

What was measured

FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P Total Score sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL.

Analysis population: Analysis was performed on FACT-P population. Number of participants analyzed=participants with evaluable FACT-P Total Score for specified outcome measure. Here, 'n' signifies number of participants with available data for specified category.

Groups in this outcome

Cabazitaxel 20 mg/m^2

Cabazitaxel 20 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.

Cabazitaxel 25 mg/m^2

Cabazitaxel 25 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.

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

Analysis denominator · Participants

GroupSource count
Cabazitaxel 20 mg/m^2521
Cabazitaxel 25 mg/m^2495

Reported measurements

Change from baseline at cycle 1 (n =521, 495)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabazitaxel 20 mg/m^25.6Not reported3.437.78Not reported
Cabazitaxel 25 mg/m^25.75Not reported3.557.95Not reported
Change from baseline at cycle 2 (n = 502, 492)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabazitaxel 20 mg/m^25.39Not reported3.237.55Not reported
Cabazitaxel 25 mg/m^26.23Not reported4.058.42Not reported
Change from baseline at cycle 3 (n = 459, 452)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabazitaxel 20 mg/m^24.39Not reported2.216.57Not reported
Cabazitaxel 25 mg/m^26.09Not reported3.898.3Not reported
Change from baseline at cycle 4 (n = 421, 415)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabazitaxel 20 mg/m^22.94Not reported0.735.14Not reported
Cabazitaxel 25 mg/m^24.2Not reported1.986.42Not reported
Change from baseline at cycle 5 (n = 339, 365)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabazitaxel 20 mg/m^21.79Not reported-0.464.04Not reported
Cabazitaxel 25 mg/m^23.33Not reported1.085.59Not reported
Change from baseline at cycle 6 (n = 275, 320)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabazitaxel 20 mg/m^22.57Not reported0.264.88Not reported
Cabazitaxel 25 mg/m^22.35Not reported0.064.64Not reported
Change from baseline at cycle 7 (n = 229, 267)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabazitaxel 20 mg/m^22.62Not reported0.254.99Not reported
Cabazitaxel 25 mg/m^22.72Not reported0.385.06Not reported
Change from baseline at cycle 8 (n = 196, 226)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabazitaxel 20 mg/m^21.35Not reported-1.083.78Not reported
Cabazitaxel 25 mg/m^21.98Not reported-0.424.37Not reported
Change from baseline at cycle 9 (n = 164, 172)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabazitaxel 20 mg/m^21.1Not reported-1.43.6Not reported
Cabazitaxel 25 mg/m^21Not reported-1.53.51Not reported
Change from baseline at cycle 10 (n = 137, 141)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabazitaxel 20 mg/m^20.02Not reported-2.572.61Not reported
Cabazitaxel 25 mg/m^21.33Not reported-1.263.93Not reported
Change from baseline at Follow-up 1 (n = 137, 153)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabazitaxel 20 mg/m^2-3.1Not reported-5.69-0.51Not reported
Cabazitaxel 25 mg/m^2-2.09Not reported-4.650.46Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.43
        upper Limit
        7.78
        value
        5.6
      2. group Id
        OG001
        lower Limit
        3.55
        upper Limit
        7.95
        value
        5.75
    title
    Change from baseline at cycle 1 (n =521, 495)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.23
        upper Limit
        7.55
        value
        5.39
      2. group Id
        OG001
        lower Limit
        4.05
        upper Limit
        8.42
        value
        6.23
    title
    Change from baseline at cycle 2 (n = 502, 492)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.21
        upper Limit
        6.57
        value
        4.39
      2. group Id
        OG001
        lower Limit
        3.89
        upper Limit
        8.3
        value
        6.09
    title
    Change from baseline at cycle 3 (n = 459, 452)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.73
        upper Limit
        5.14
        value
        2.94
      2. group Id
        OG001
        lower Limit
        1.98
        upper Limit
        6.42
        value
        4.2
    title
    Change from baseline at cycle 4 (n = 421, 415)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.46
        upper Limit
        4.04
        value
        1.79
      2. group Id
        OG001
        lower Limit
        1.08
        upper Limit
        5.59
        value
        3.33
    title
    Change from baseline at cycle 5 (n = 339, 365)
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.26
        upper Limit
        4.88
        value
        2.57
      2. group Id
        OG001
        lower Limit
        0.06
        upper Limit
        4.64
        value
        2.35
    title
    Change from baseline at cycle 6 (n = 275, 320)
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.25
        upper Limit
        4.99
        value
        2.62
      2. group Id
        OG001
        lower Limit
        0.38
        upper Limit
        5.06
        value
        2.72
    title
    Change from baseline at cycle 7 (n = 229, 267)
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -1.08
        upper Limit
        3.78
        value
        1.35
      2. group Id
        OG001
        lower Limit
        -0.42
        upper Limit
        4.37
        value
        1.98
    title
    Change from baseline at cycle 8 (n = 196, 226)
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -1.4
        upper Limit
        3.6
        value
        1.1
      2. group Id
        OG001
        lower Limit
        -1.5
        upper Limit
        3.51
        value
        1
    title
    Change from baseline at cycle 9 (n = 164, 172)
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -2.57
        upper Limit
        2.61
        value
        0.02
      2. group Id
        OG001
        lower Limit
        -1.26
        upper Limit
        3.93
        value
        1.33
    title
    Change from baseline at cycle 10 (n = 137, 141)
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -5.69
        upper Limit
        -0.51
        value
        -3.1
      2. group Id
        OG001
        lower Limit
        -4.65
        upper Limit
        0.46
        value
        -2.09
    title
    Change from baseline at Follow-up 1 (n = 137, 153)
denoms
  1. counts
    1. group Id
      OG000
      value
      521
    2. group Id
      OG001
      value
      495
    units
    Participants
description
FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P Total Score sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL.
dispersion Type
95% Confidence Interval
groups
  1. description
    Cabazitaxel 20 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
    id
    OG000
    title
    Cabazitaxel 20 mg/m^2
  2. description
    Cabazitaxel 25 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
    id
    OG001
    title
    Cabazitaxel 25 mg/m^2
param Type
LEAST_SQUARES_MEAN
population Description
Analysis was performed on FACT-P population. Number of participants analyzed=participants with evaluable FACT-P Total Score for specified outcome measure. Here, 'n' signifies number of participants with available data for specified category.
reporting Status
POSTED
time Frame
Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks)
title
Change From Baseline in FACT-P:Total Score as a Measure of HRQoL
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice