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NCT00789373 · OUTCOME

Percentage of Participants With a Non-Serious Adverse Event (AE) During Maintenance Phase

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 randomization through 30-day post-discontinuation visit (up to 49.7 months)

What was measured

A summary of non-serious AEs is located in the Reported Adverse Event Module.

Analysis population: Randomized population with 2% cut-off threshold for inclusion for 19.3 months and 5% for 49.7 months.

Groups in this outcome

Pemetrexed Plus Cisplatin Followed by Maintenance Pemetrexed

pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care

Pemetrexed Plus 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 Plus Cisplatin Followed by Placebo180

Reported measurements

Non-Serious AEs at 2% Threshold: up to 19.3 Month
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemetrexed Plus Cisplatin Followed by Maintenance Pemetrexed59.9Not reportedNot reportedNot reportedNot reported
Pemetrexed Plus Cisplatin Followed by Placebo50.6Not reportedNot reportedNot reportedNot reported
Non-Serious AEs at 5% Threshold: up to 49.7 Months
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemetrexed Plus Cisplatin Followed by Maintenance Pemetrexed75.5Not reportedNot reportedNot reportedNot reported
Pemetrexed Plus Cisplatin Followed by Placebo62.2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        59.9
      2. group Id
        OG001
        value
        50.6
    title
    Non-Serious AEs at 2% Threshold: up to 19.3 Month
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        75.5
      2. group Id
        OG001
        value
        62.2
    title
    Non-Serious AEs at 5% Threshold: up to 49.7 Months
denoms
  1. counts
    1. group Id
      OG000
      value
      359
    2. group Id
      OG001
      value
      180
    units
    Participants
description
A summary of non-serious AEs is located in the Reported Adverse Event Module.
groups
  1. description
    pemetrexed and cisplatin followed by maintenance pemetrexed plus 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 Plus Cisplatin Followed by Placebo
param Type
NUMBER
population Description
Randomized population with 2% cut-off threshold for inclusion for 19.3 months and 5% for 49.7 months.
reporting Status
POSTED
time Frame
Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months)
title
Percentage of Participants With a Non-Serious Adverse Event (AE) During Maintenance Phase
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice