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NCT01801436 · OUTCOME

Number of Participants With KPS Score at Day 1 of Cycle 3

A Post-Approval Pharmacokinetic Study of Bortezomib in Participants With Multiple Myeloma · Source last updated 2013-05-16

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

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Day 1 of Cycle 3

What was measured

The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.

Analysis population: The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data. Here 'N' signifies those participants who were evaluated for this outcome measures.

Groups in this outcome

Bortezomib

Participants received 1.3 mg per m\^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 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
Bortezomib12

Reported measurements

KPS Score = 60
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib1Not reportedNot reportedNot reportedNot reported
KPS Score = 70
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib1Not reportedNot reportedNot reportedNot reported
KPS Score = 80
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib6Not reportedNot reportedNot reportedNot reported
KPS Score = 90
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib2Not reportedNot reportedNot reportedNot reported
KPS Score = 100
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    KPS Score = 60
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    KPS Score = 70
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    KPS Score = 80
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    KPS Score = 90
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    KPS Score = 100
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    units
    Participants
description
The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.
groups
  1. description
    Participants received 1.3 mg per m\^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
    id
    OG000
    title
    Bortezomib
param Type
NUMBER
population Description
The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data. Here 'N' signifies those participants who were evaluated for this outcome measures.
reporting Status
POSTED
time Frame
Day 1 of Cycle 3
title
Number of Participants With KPS Score at Day 1 of Cycle 3
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice