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NCT01308580 · OUTCOME

Time to Definitive Deterioration of Score by 10% From Baseline on FACT-P Sub-Scales

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)

What was measured

The time to definitive deterioration (10% decrease in score from baseline) was assessed for the individual sub-scales (Physical Well-Being; Social/Family Well-Being; Emotional Well-Being; Functional Well-Being; Prostate-Specific Concerns). Analysis was performed by Kaplan-Meier method.

Analysis population: Analysis was performed on FACT-P population.

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^2557
Cabazitaxel 25 mg/m^2543

Reported measurements

Physical well-being
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabazitaxel 20 mg/m^26.6Not reported5.857.82Not reported
Cabazitaxel 25 mg/m^28.3Not reported7.168.74Not reported
Social/family well-being
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabazitaxel 20 mg/m^210.8Not reported9.2613.37Not reported
Cabazitaxel 25 mg/m^212.4Not reported8.9713.83Not reported
Emotional well-being
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabazitaxel 20 mg/m^29.7Not reported7.3611.30Not reported
Cabazitaxel 25 mg/m^29.9Not reported8.5412.52Not reported
Functional well-being
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabazitaxel 20 mg/m^26.6Not reported5.557.43Not reported
Cabazitaxel 25 mg/m^26.7Not reported6.018.34Not reported
Prostate specific concern
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabazitaxel 20 mg/m^28.7Not reported7.629.66Not reported
Cabazitaxel 25 mg/m^29.7Not reported8.7710.87Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.85
        upper Limit
        7.82
        value
        6.6
      2. group Id
        OG001
        lower Limit
        7.16
        upper Limit
        8.74
        value
        8.3
    title
    Physical well-being
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.26
        upper Limit
        13.37
        value
        10.8
      2. group Id
        OG001
        lower Limit
        8.97
        upper Limit
        13.83
        value
        12.4
    title
    Social/family well-being
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.36
        upper Limit
        11.30
        value
        9.7
      2. group Id
        OG001
        lower Limit
        8.54
        upper Limit
        12.52
        value
        9.9
    title
    Emotional well-being
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.55
        upper Limit
        7.43
        value
        6.6
      2. group Id
        OG001
        lower Limit
        6.01
        upper Limit
        8.34
        value
        6.7
    title
    Functional well-being
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.62
        upper Limit
        9.66
        value
        8.7
      2. group Id
        OG001
        lower Limit
        8.77
        upper Limit
        10.87
        value
        9.7
    title
    Prostate specific concern
denoms
  1. counts
    1. group Id
      OG000
      value
      557
    2. group Id
      OG001
      value
      543
    units
    Participants
description
The time to definitive deterioration (10% decrease in score from baseline) was assessed for the individual sub-scales (Physical Well-Being; Social/Family Well-Being; Emotional Well-Being; Functional Well-Being; Prostate-Specific Concerns). Analysis was performed by Kaplan-Meier method.
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
MEDIAN
population Description
Analysis was performed on FACT-P population.
reporting Status
POSTED
time Frame
From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)
title
Time to Definitive Deterioration of Score by 10% From Baseline on FACT-P Sub-Scales
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice