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NCT00789373 · OUTCOME

Percentage of Participants With Objective Tumor Response (Response Rate) During Maintenance Phase of Study up to Primary Data Cut-Off

A Study of Induction and Maintenance Treatment of Advanced Non-squamous Non-Small Cell Lung Cancer · Source last updated 2018-12-14

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Baseline to date of measured progressive disease (up to 19.3 months)

What was measured

Analysis for combined phases was not performed since response was calculated separately for each phase of study. Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response(PR)is at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease(PD) is at least a 20% increase in sum of longest diameter of target lesions; Stable Disease(SD)=no change or small changes that do not meet the above criteria for CR, PR, or PD.

Analysis population: All randomized participants

Groups in this outcome

Pemetrexed Plus Cisplatin Followed by Maintenance Pemetrexed

pemetrexed and cisplatin followed by maintenance pemetrexed and best supportive care

Pemetrexed + Cisplatin Followed by Placebo

pemetrexed + cisplatin followed by placebo plus best supportive care

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

Analysis denominator · Participants

GroupSource count
Pemetrexed Plus Cisplatin Followed by Maintenance Pemetrexed359
Pemetrexed + Cisplatin Followed by Placebo180

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemetrexed Plus Cisplatin Followed by Maintenance Pemetrexed46.2Not reportedNot reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo42.2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        46.2
      2. group Id
        OG001
        value
        42.2
denoms
  1. counts
    1. group Id
      OG000
      value
      359
    2. group Id
      OG001
      value
      180
    units
    Participants
description
Analysis for combined phases was not performed since response was calculated separately for each phase of study. Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response(PR)is at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease(PD) is at least a 20% increase in sum of longest diameter of target lesions; Stable Disease(SD)=no change or small changes that do not meet the above criteria for CR, PR, or PD.
groups
  1. description
    pemetrexed and cisplatin followed by maintenance pemetrexed and best supportive care
    id
    OG000
    title
    Pemetrexed Plus Cisplatin Followed by Maintenance Pemetrexed
  2. description
    pemetrexed + cisplatin followed by placebo plus best supportive care
    id
    OG001
    title
    Pemetrexed + Cisplatin Followed by Placebo
param Type
NUMBER
population Description
All randomized participants
reporting Status
POSTED
time Frame
Baseline to date of measured progressive disease (up to 19.3 months)
title
Percentage of Participants With Objective Tumor Response (Response Rate) During Maintenance Phase of Study up to Primary Data Cut-Off
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice