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NCT01282424 · OUTCOME

Change in Karnofsky Performance Status

Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin Lymphomas · Source last updated 2019-07-11

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 to End of Treatment (up to 81 months)

What was measured

The change in Karnofsky performance status was reported as the best (highest change score) and worst (lowest change score) change from baseline using the Karnofsky performance criteria. The Karnofsky score classified participants according to their functional impairment. Scores are on a scale from 0-100, the lower the score, the worse the survival for most serious illnesses.

Analysis population: Participants in the ITT Analysis Set with available data were analyzed.

Groups in this outcome

Idelalisib

Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Idelalisib122

Reported measurements

Best change
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Idelalisib3.08.71Not reportedNot reportedNot reported
Worst change
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Idelalisib-10.712.61Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.71
        value
        3.0
    title
    Best change
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.61
        value
        -10.7
    title
    Worst change
denoms
  1. counts
    1. group Id
      OG000
      value
      122
    units
    Participants
description
The change in Karnofsky performance status was reported as the best (highest change score) and worst (lowest change score) change from baseline using the Karnofsky performance criteria. The Karnofsky score classified participants according to their functional impairment. Scores are on a scale from 0-100, the lower the score, the worse the survival for most serious illnesses.
dispersion Type
Standard Deviation
groups
  1. description
    Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
    id
    OG000
    title
    Idelalisib
param Type
MEAN
population Description
Participants in the ITT Analysis Set with available data were analyzed.
reporting Status
POSTED
time Frame
Baseline to End of Treatment (up to 81 months)
title
Change in 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