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NCT01308567 · OUTCOME

Percentage of Participants With Pain Response

Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer · Source last updated 2019-06-05

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Baseline until pain progression, death or study cut-off date (maximum duration: 51 months)

What was measured

Pain response was defined as either a ≥2-point decrease from baseline median PPI score without increase in analgesic score, or a ≥50% decrease in analgesic use from baseline mean analgesic score (only in participants with baseline mean analgesic score≥10) without increase in the pain. Either criterion was maintained for 2 consecutive evaluations at least 3 weeks apart. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. Analgesic score was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points.

Analysis population: Analysis was performed on ITT population. Number of participants analyzed=participants with pain score with median PPI \>= 2 and/or mean analgesic score \>= 10 points at baseline and at least one valid post-baseline value for specified outcome measure.

Groups in this outcome

Docetaxel 75 mg/m^2

Docetaxel (TXT) 75 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.

Cabazitaxel 20 mg/m^2

Cabazitaxel 20 mg/m\^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.

Cabazitaxel 25 mg/m^2

Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.

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

Analysis denominator · Participants

GroupSource count
Docetaxel 75 mg/m^281
Cabazitaxel 20 mg/m^299
Cabazitaxel 25 mg/m^2104

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Docetaxel 75 mg/m^240.7Not reported30.051.4Not reported
Cabazitaxel 20 mg/m^242.4Not reported32.752.2Not reported
Cabazitaxel 25 mg/m^239.4Not reported30.048.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        30.0
        upper Limit
        51.4
        value
        40.7
      2. group Id
        OG001
        lower Limit
        32.7
        upper Limit
        52.2
        value
        42.4
      3. group Id
        OG002
        lower Limit
        30.0
        upper Limit
        48.8
        value
        39.4
denoms
  1. counts
    1. group Id
      OG000
      value
      81
    2. group Id
      OG001
      value
      99
    3. group Id
      OG002
      value
      104
    units
    Participants
description
Pain response was defined as either a ≥2-point decrease from baseline median PPI score without increase in analgesic score, or a ≥50% decrease in analgesic use from baseline mean analgesic score (only in participants with baseline mean analgesic score≥10) without increase in the pain. Either criterion was maintained for 2 consecutive evaluations at least 3 weeks apart. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. Analgesic score was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points.
dispersion Type
95% Confidence Interval
groups
  1. description
    Docetaxel (TXT) 75 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
    id
    OG000
    title
    Docetaxel 75 mg/m^2
  2. description
    Cabazitaxel 20 mg/m\^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
    id
    OG001
    title
    Cabazitaxel 20 mg/m^2
  3. description
    Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
    id
    OG002
    title
    Cabazitaxel 25 mg/m^2
param Type
NUMBER
population Description
Analysis was performed on ITT population. Number of participants analyzed=participants with pain score with median PPI \>= 2 and/or mean analgesic score \>= 10 points at baseline and at least one valid post-baseline value for specified outcome measure.
reporting Status
POSTED
time Frame
Baseline until pain progression, death or study cut-off date (maximum duration: 51 months)
title
Percentage of Participants With Pain Response
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice