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NCT00339183 · OUTCOME

Duration of Response

Comparison of Treatment Effect of Chemotherapy With Panitumumab to Chemotherapy Alone · Source last updated 2022-09-23

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months

What was measured

Calculated only for those participants with an objective response as the time from the first objective response (subsequently confirmed within no less than 4 weeks) to first observed disease progression per modified-RECIST criteria. Participants not meeting these criteria by the analysis data cutoff date were censored at their last evaluable disease assessment date. Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions.

Analysis population: KRAS Central Tumor Response Analysis Set: Responders

Groups in this outcome

Wild-type KRAS - Panitumumab Plus FOLFIRI

Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.

Wild-type KRAS - FOLFIRI Alone

Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.

Mutant KRAS - Panitumumab Plus FOLFIRI

Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.

Mutant KRAS - FOLFIRI Alone

Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.

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

Analysis denominator · Participants

GroupSource count
Wild-type KRAS - Panitumumab Plus FOLFIRI105
Wild-type KRAS - FOLFIRI Alone28
Mutant KRAS - Panitumumab Plus FOLFIRI31
Mutant KRAS - FOLFIRI Alone33

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Wild-type KRAS - Panitumumab Plus FOLFIRI7.6Not reported6.79.4Not reported
Wild-type KRAS - FOLFIRI Alone6.6Not reported5.710.4Not reported
Mutant KRAS - Panitumumab Plus FOLFIRI6.0Not reported5.47.4Not reported
Mutant KRAS - FOLFIRI Alone7.4Not reported4.08.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.7
        upper Limit
        9.4
        value
        7.6
      2. group Id
        OG001
        lower Limit
        5.7
        upper Limit
        10.4
        value
        6.6
      3. group Id
        OG002
        lower Limit
        5.4
        upper Limit
        7.4
        value
        6.0
      4. group Id
        OG003
        lower Limit
        4.0
        upper Limit
        8.1
        value
        7.4
denoms
  1. counts
    1. group Id
      OG000
      value
      105
    2. group Id
      OG001
      value
      28
    3. group Id
      OG002
      value
      31
    4. group Id
      OG003
      value
      33
    units
    Participants
description
Calculated only for those participants with an objective response as the time from the first objective response (subsequently confirmed within no less than 4 weeks) to first observed disease progression per modified-RECIST criteria. Participants not meeting these criteria by the analysis data cutoff date were censored at their last evaluable disease assessment date. Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
    id
    OG000
    title
    Wild-type KRAS - Panitumumab Plus FOLFIRI
  2. description
    Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
    id
    OG001
    title
    Wild-type KRAS - FOLFIRI Alone
  3. description
    Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
    id
    OG002
    title
    Mutant KRAS - Panitumumab Plus FOLFIRI
  4. description
    Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
    id
    OG003
    title
    Mutant KRAS - FOLFIRI Alone
param Type
MEDIAN
population Description
KRAS Central Tumor Response Analysis Set: Responders
reporting Status
POSTED
time Frame
From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months
title
Duration of Response
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Independent clinical review pending · Not medical advice