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NCT00789373 · OUTCOME

Percentage of Participants With Independently-Assessed Objective Tumor Response (Response Rate) During Maintenance Phase 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
95% Confidence Interval
Time frame
Date of randomization to date of measured PD (up to 19.3 months)

What was measured

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. Response Rate = (CR+PR)/Participants in Arm\*100. Disease Control Rate=(CR+PR+SD)/Number of Participants in Arm\*100.

Analysis population: All randomized participants

Groups in this outcome

Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed

pemetrexed and cisplatin followed by maintenance pemetrexed plus 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 + Cisplatin Followed by Maintenance Pemetrexed359
Pemetrexed + Cisplatin Followed by Placebo180

Reported measurements

Response Rate
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed46.2Not reported41.051.6Not reported
Pemetrexed + Cisplatin Followed by Placebo42.2Not reported34.949.8Not reported
Disease Control Rate
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed98.1Not reported96.099.2Not reported
Pemetrexed + Cisplatin Followed by Placebo94.4Not reported90.097.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        41.0
        upper Limit
        51.6
        value
        46.2
      2. group Id
        OG001
        lower Limit
        34.9
        upper Limit
        49.8
        value
        42.2
    title
    Response Rate
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        96.0
        upper Limit
        99.2
        value
        98.1
      2. group Id
        OG001
        lower Limit
        90.0
        upper Limit
        97.3
        value
        94.4
    title
    Disease Control Rate
denoms
  1. counts
    1. group Id
      OG000
      value
      359
    2. group Id
      OG001
      value
      180
    units
    Participants
description
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. Response Rate = (CR+PR)/Participants in Arm\*100. Disease Control Rate=(CR+PR+SD)/Number of Participants in Arm\*100.
dispersion Type
95% Confidence Interval
groups
  1. description
    pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
    id
    OG000
    title
    Pemetrexed + 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
Date of randomization to date of measured PD (up to 19.3 months)
title
Percentage of Participants With Independently-Assessed Objective Tumor Response (Response Rate) During Maintenance Phase 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