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NCT01286077 · OUTCOME

Karnofsky Performance Status

Velcade Consolidation Bone Study · Source last updated 2016-05-30

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 up to end of study (approximately 4 years 7 months)

What was measured

The Karnofsky performance status is a way to quantify cancer patients' general well-being and activities of daily life and runs from 100 to 0, where 100 is "perfect" health and 0 is death.

Analysis population: FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. "N" (number of subjects analyzed) signifies the subjects evaluable this measure. Missing data was imputed by last observation carried forward (LOCF) method.

Groups in this outcome

Bortezomib

bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles

Non-treated Control

no treatment, observation only

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

Analysis denominator · Participants

GroupSource count
Bortezomib46
Non-treated Control47

Reported measurements

Screening
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bortezomib92.49.2Not reportedNot reportedNot reported
Non-treated Control91.77.0Not reportedNot reportedNot reported
Follow-up
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bortezomib0.011.4Not reportedNot reportedNot reported
Non-treated Control0.47.5Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.2
        value
        92.4
      2. group Id
        OG001
        spread
        7.0
        value
        91.7
    title
    Screening
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.4
        value
        0.0
      2. group Id
        OG001
        spread
        7.5
        value
        0.4
    title
    Follow-up
denoms
  1. counts
    1. group Id
      OG000
      value
      46
    2. group Id
      OG001
      value
      47
    units
    Participants
description
The Karnofsky performance status is a way to quantify cancer patients' general well-being and activities of daily life and runs from 100 to 0, where 100 is "perfect" health and 0 is death.
dispersion Type
Standard Deviation
groups
  1. description
    bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
    id
    OG000
    title
    Bortezomib
  2. description
    no treatment, observation only
    id
    OG001
    title
    Non-treated Control
param Type
MEAN
population Description
FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. "N" (number of subjects analyzed) signifies the subjects evaluable this measure. Missing data was imputed by last observation carried forward (LOCF) method.
reporting Status
POSTED
time Frame
Baseline up to end of study (approximately 4 years 7 months)
title
Karnofsky Performance Status
type
SECONDARY
unit Of Measure
Units on a scale

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

Preserved source evidence · Not medical advice