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NCT01308580 · OUTCOME

Time to Definitive Weight Loss by 5% and 10% From Baseline

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 death or study cut-off date (maximum duration: 48 months)

What was measured

Time to definitive weight loss was defined as the time to first occurrence of ≥5% or ≥10% decrease in body weight from baseline. Analysis was performed by Kaplan-Meier method.

Analysis population: Analysis was performed on ITT 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^2598
Cabazitaxel 25 mg/m^2602

Reported measurements

Weight Loss by 5%
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabazitaxel 20 mg/m^210.6Not reported9.2613.17Not reported
Cabazitaxel 25 mg/m^211.1Not reported10.1212.42Not reported
Weight Loss by 10%
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabazitaxel 20 mg/m^2NANot reported12.65NAThe median and upper bound of the confidence interval could not be calculated using the Kaplan-Meier method
Cabazitaxel 25 mg/m^220.3Not reported14.23NAThe upper bound of the confidence interval could not be calculated using the Kaplan-Meier method
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.26
        upper Limit
        13.17
        value
        10.6
      2. group Id
        OG001
        lower Limit
        10.12
        upper Limit
        12.42
        value
        11.1
    title
    Weight Loss by 5%
  2. categories
    1. measurements
      1. comment
        The median and upper bound of the confidence interval could not be calculated using the Kaplan-Meier method
        group Id
        OG000
        lower Limit
        12.65
        upper Limit
        NA
        value
        NA
      2. comment
        The upper bound of the confidence interval could not be calculated using the Kaplan-Meier method
        group Id
        OG001
        lower Limit
        14.23
        upper Limit
        NA
        value
        20.3
    title
    Weight Loss by 10%
denoms
  1. counts
    1. group Id
      OG000
      value
      598
    2. group Id
      OG001
      value
      602
    units
    Participants
description
Time to definitive weight loss was defined as the time to first occurrence of ≥5% or ≥10% decrease in body weight from baseline. 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 ITT population.
reporting Status
POSTED
time Frame
From baseline until death or study cut-off date (maximum duration: 48 months)
title
Time to Definitive Weight Loss by 5% and 10% From Baseline
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice