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NCT00364013 · OUTCOME

Time to Progression

PRIME: Panitumumab Randomized Trial In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy · Source last updated 2022-11-07

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 September 2008; Maximum follow-up time was 109 weeks.

What was measured

Time to progression was defined as time from randomization date to date of disease progression per the modified RECIST criteria.

Analysis population: KRAS Efficacy Analysis Set

Groups in this outcome

Wild-type KRAS - FOLFOX + Panitumumab

Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.

Wild-type KRAS - FOLFOX

Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.

Mutant KRAS - FOLFOX + Panitumumab

Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.

Mutant KRAS - FOLFOX

Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until 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
Wild-type KRAS - FOLFOX + Panitumumab325
Wild-type KRAS - FOLFOX331
Mutant KRAS - FOLFOX + Panitumumab221
Mutant KRAS - FOLFOX219

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Wild-type KRAS - FOLFOX + Panitumumab10.8Not reported9.412.4Not reported
Wild-type KRAS - FOLFOX9.2Not reported7.79.9Not reported
Mutant KRAS - FOLFOX + Panitumumab7.5Not reported7.28.9Not reported
Mutant KRAS - FOLFOX9.0Not reported7.79.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.4
        upper Limit
        12.4
        value
        10.8
      2. group Id
        OG001
        lower Limit
        7.7
        upper Limit
        9.9
        value
        9.2
      3. group Id
        OG002
        lower Limit
        7.2
        upper Limit
        8.9
        value
        7.5
      4. group Id
        OG003
        lower Limit
        7.7
        upper Limit
        9.5
        value
        9.0
denoms
  1. counts
    1. group Id
      OG000
      value
      325
    2. group Id
      OG001
      value
      331
    3. group Id
      OG002
      value
      221
    4. group Id
      OG003
      value
      219
    units
    Participants
description
Time to progression was defined as time from randomization date to date of disease progression per the modified RECIST criteria.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
    id
    OG000
    title
    Wild-type KRAS - FOLFOX + Panitumumab
  2. description
    Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
    id
    OG001
    title
    Wild-type KRAS - FOLFOX
  3. description
    Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
    id
    OG002
    title
    Mutant KRAS - FOLFOX + Panitumumab
  4. description
    Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
    id
    OG003
    title
    Mutant KRAS - FOLFOX
param Type
MEDIAN
population Description
KRAS Efficacy Analysis Set
reporting Status
POSTED
time Frame
From randomization until the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks.
title
Time to 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