Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02426125 · OUTCOME

Time to Deterioration in Quality of Life (QoL) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status/ QoL Scale

A Study of Ramucirumab (LY3009806) Plus Docetaxel in Participants With Urothelial Cancer · Source last updated 2023-08-21

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
Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months)

What was measured

Time to sustained deterioration was defined as time from randomization to first worsening in QoL with no subsequent non-worsened assessment. Worsening in global health status/QoL was defined as a decrease of ≥10 points on a 100-point scale. If a participant did not report worsening, time to sustained deterioration was censored at date of last non-worsened assessment. Scores for global health status/QoL range from 0 to 100 with; higher scores representing better QoL.

Analysis population: All randomized participants. Censored participants: Ramucirumab + Docetaxel = 160, Placebo + Docetaxel = 173.

Groups in this outcome

Ramucirumab + Docetaxel

Ramucirumab (10 mg/kg) IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Placebo + Docetaxel

Placebo IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

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

Analysis denominator · Participants

GroupSource count
Ramucirumab + Docetaxel263
Placebo + Docetaxel267

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ramucirumab + Docetaxel6.87Not reported4.248.90Not reported
Placebo + Docetaxel4.60Not reported3.525.55Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.663
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.167
    estimate Comment
    Stratified
    group Description
    Global health status/QoL
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.357
    p Value Comment
    Stratified
    param Type
    Hazard Ratio (HR)
    param Value
    0.879
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.663
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.167
    estimate Comment
    Stratified
    group Description
    Global health status/QoL
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.357
    p Value Comment
    Stratified
    param Type
    Hazard Ratio (HR)
    param Value
    0.879
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.24
        upper Limit
        8.90
        value
        6.87
      2. group Id
        OG001
        lower Limit
        3.52
        upper Limit
        5.55
        value
        4.60
denoms
  1. counts
    1. group Id
      OG000
      value
      263
    2. group Id
      OG001
      value
      267
    units
    Participants
description
Time to sustained deterioration was defined as time from randomization to first worsening in QoL with no subsequent non-worsened assessment. Worsening in global health status/QoL was defined as a decrease of ≥10 points on a 100-point scale. If a participant did not report worsening, time to sustained deterioration was censored at date of last non-worsened assessment. Scores for global health status/QoL range from 0 to 100 with; higher scores representing better QoL.
dispersion Type
95% Confidence Interval
groups
  1. description
    Ramucirumab (10 mg/kg) IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
    id
    OG000
    title
    Ramucirumab + Docetaxel
  2. description
    Placebo IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
    id
    OG001
    title
    Placebo + Docetaxel
param Type
MEDIAN
population Description
All randomized participants. Censored participants: Ramucirumab + Docetaxel = 160, Placebo + Docetaxel = 173.
reporting Status
POSTED
time Frame
Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months)
title
Time to Deterioration in Quality of Life (QoL) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status/ QoL Scale
type
SECONDARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice