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NCT00339183 · OUTCOME

Time to Disease Progression

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

Time to progression was defined as the time from the randomization date to the date of first observed disease progression per the 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 Efficacy Analysis Set

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 FOLFIRI303
Wild-type KRAS - FOLFIRI Alone294
Mutant KRAS - Panitumumab Plus FOLFIRI238
Mutant KRAS - FOLFIRI Alone248

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Wild-type KRAS - Panitumumab Plus FOLFIRI7.3Not reported5.97.5Not reported
Wild-type KRAS - FOLFIRI Alone5.3Not reported3.95.7Not reported
Mutant KRAS - Panitumumab Plus FOLFIRI5.5Not reported4.55.7Not reported
Mutant KRAS - FOLFIRI Alone5.5Not reported4.25.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.9
        upper Limit
        7.5
        value
        7.3
      2. group Id
        OG001
        lower Limit
        3.9
        upper Limit
        5.7
        value
        5.3
      3. group Id
        OG002
        lower Limit
        4.5
        upper Limit
        5.7
        value
        5.5
      4. group Id
        OG003
        lower Limit
        4.2
        upper Limit
        5.7
        value
        5.5
denoms
  1. counts
    1. group Id
      OG000
      value
      303
    2. group Id
      OG001
      value
      294
    3. group Id
      OG002
      value
      238
    4. group Id
      OG003
      value
      248
    units
    Participants
description
Time to progression was defined as the time from the randomization date to the date of first observed disease progression per the 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 Efficacy Analysis Set
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
Time to Disease Progression
type
SECONDARY
unit Of Measure
months

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

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