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NCT00738530 · OUTCOME

Change From Baseline in Karnofsky Performance Status

A Study of Avastin (Bevacizumab) Added to Interferon Alfa-2a (Roferon) Therapy in Patients With Metastatic Renal Cell Cancer With Nephrectomy · Source last updated 2016-06-23

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

Measure
MEDIAN
Unit
score on a scale
Interval / dispersion
Full Range
Time frame
Baseline, Week 7, 15, 23, 31, 43

What was measured

Karnofsky performance score is used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. Karnofsky performance score is 11 level score which ranges between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks.

Analysis population: Safety population: all participants randomized and exposed to study drug (8 randomized participants did not receive study treatment and were not included, 2 in bevacizumab and 6 in placebo group). 12 participants randomized to placebo received bevacizumab, were included in bevacizumab arm. n=number of evaluable participants at specified time point.

Groups in this outcome

Bevacizumab + IFN-Alfa-2A

Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.

Placebo + IFN-Alfa-2A

Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major 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
Bevacizumab + IFN-Alfa-2A337
Placebo + IFN-Alfa-2A304

Reported measurements

Baseline (n=337, 304)
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bevacizumab + IFN-Alfa-2A90Not reported70100Not reported
Placebo + IFN-Alfa-2A90Not reported70100Not reported
Change at Week 7 (n=291, 263)
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bevacizumab + IFN-Alfa-2A0Not reported-5010Not reported
Placebo + IFN-Alfa-2A0Not reported-6020Not reported
Change at Week 15 (n=242, 196)
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bevacizumab + IFN-Alfa-2A0Not reported-4020Not reported
Placebo + IFN-Alfa-2A0Not reported-6020Not reported
Change at Week 23 (n=195, 143)
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bevacizumab + IFN-Alfa-2A0Not reported-9020Not reported
Placebo + IFN-Alfa-2A0Not reported-6020Not reported
Change at Week 31 (n=166, 108)
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bevacizumab + IFN-Alfa-2A0Not reported-4020Not reported
Placebo + IFN-Alfa-2A0Not reported-5020Not reported
Change at Week 43 (n=137, 79)
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bevacizumab + IFN-Alfa-2A0Not reported-4020Not reported
Placebo + IFN-Alfa-2A0Not reported-2010Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        70
        upper Limit
        100
        value
        90
      2. group Id
        OG001
        lower Limit
        70
        upper Limit
        100
        value
        90
    title
    Baseline (n=337, 304)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -50
        upper Limit
        10
        value
        0
      2. group Id
        OG001
        lower Limit
        -60
        upper Limit
        20
        value
        0
    title
    Change at Week 7 (n=291, 263)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -40
        upper Limit
        20
        value
        0
      2. group Id
        OG001
        lower Limit
        -60
        upper Limit
        20
        value
        0
    title
    Change at Week 15 (n=242, 196)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -90
        upper Limit
        20
        value
        0
      2. group Id
        OG001
        lower Limit
        -60
        upper Limit
        20
        value
        0
    title
    Change at Week 23 (n=195, 143)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -40
        upper Limit
        20
        value
        0
      2. group Id
        OG001
        lower Limit
        -50
        upper Limit
        20
        value
        0
    title
    Change at Week 31 (n=166, 108)
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -40
        upper Limit
        20
        value
        0
      2. group Id
        OG001
        lower Limit
        -20
        upper Limit
        10
        value
        0
    title
    Change at Week 43 (n=137, 79)
denoms
  1. counts
    1. group Id
      OG000
      value
      337
    2. group Id
      OG001
      value
      304
    units
    Participants
description
Karnofsky performance score is used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. Karnofsky performance score is 11 level score which ranges between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks.
dispersion Type
Full Range
groups
  1. description
    Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
    id
    OG000
    title
    Bevacizumab + IFN-Alfa-2A
  2. description
    Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
    id
    OG001
    title
    Placebo + IFN-Alfa-2A
param Type
MEDIAN
population Description
Safety population: all participants randomized and exposed to study drug (8 randomized participants did not receive study treatment and were not included, 2 in bevacizumab and 6 in placebo group). 12 participants randomized to placebo received bevacizumab, were included in bevacizumab arm. n=number of evaluable participants at specified time point.
reporting Status
POSTED
time Frame
Baseline, Week 7, 15, 23, 31, 43
title
Change From Baseline in Karnofsky Performance Status
type
SECONDARY
unit Of Measure
score on a scale

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Preserved source evidence · Not medical advice