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NCT02426125 · OUTCOME

Overall Survival (OS)

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 to Date of Death from Any Cause (Up to 31.1 Months)

What was measured

OS is the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data inclusion cutoff date for a particular analysis, OS was censored for that analysis at the last known alive date prior to the data inclusion cutoff date.

Analysis population: All randomized participants. Censored participants: Ramucirumab + Docetaxel = 78, Placebo + Docetaxel = 67.

Groups in this outcome

Ramucirumab + Docetaxel

Ramucirumab (10 mg/kg) IV plus docetaxel 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 + Docetaxel9.40Not reported7.8911.43Not reported
Placebo + Docetaxel7.85Not reported7.009.30Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.724
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.086
    estimate Comment
    Stratified
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2461
    p Value Comment
    Stratified
    param Type
    Hazard Ratio (HR)
    param Value
    0.887
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.724
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.086
    estimate Comment
    Stratified
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2461
    p Value Comment
    Stratified
    param Type
    Hazard Ratio (HR)
    param Value
    0.887
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.89
        upper Limit
        11.43
        value
        9.40
      2. group Id
        OG001
        lower Limit
        7.00
        upper Limit
        9.30
        value
        7.85
denoms
  1. counts
    1. group Id
      OG000
      value
      263
    2. group Id
      OG001
      value
      267
    units
    Participants
description
OS is the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data inclusion cutoff date for a particular analysis, OS was censored for that analysis at the last known alive date prior to the data inclusion cutoff date.
dispersion Type
95% Confidence Interval
groups
  1. description
    Ramucirumab (10 mg/kg) IV plus docetaxel 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 = 78, Placebo + Docetaxel = 67.
reporting Status
POSTED
time Frame
Randomization to Date of Death from Any Cause (Up to 31.1 Months)
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice