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NCT02426125 · OUTCOME

Progression Free Survival (PFS)

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 Radiological Disease Progression or Death from Any Cause (Up to 18 Months)

What was measured

PFS defined as time from first day of therapy to first evidence of disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause. Progressive Disease (PD) is at least 20% increase in sum of diameters of target lesions, with reference being the smallest sum on study and plus absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If participant does not have complete baseline disease assessment, then PFS time was censored at date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for participant. If participant is not known to have died or have objective progression as of data inclusion cutoff date for analysis, PFS time was censored at last adequate tumor assessment date.

Analysis population: The first randomized participants. Censored participants: Ramucirumab + Docetaxel = 58, Placebo + Docetaxel =38.

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 + Docetaxel216
Placebo + Docetaxel221

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ramucirumab + Docetaxel4.07Not reported2.964.47Not reported
Placebo + Docetaxel2.76Not reported2.602.96Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.607
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.943
    estimate Comment
    Stratified
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0118
    p Value Comment
    Stratified
    param Type
    Hazard Ratio (HR)
    param Value
    0.757
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.607
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.943
    estimate Comment
    Stratified
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0118
    p Value Comment
    Stratified
    param Type
    Hazard Ratio (HR)
    param Value
    0.757
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.96
        upper Limit
        4.47
        value
        4.07
      2. group Id
        OG001
        lower Limit
        2.60
        upper Limit
        2.96
        value
        2.76
denoms
  1. counts
    1. group Id
      OG000
      value
      216
    2. group Id
      OG001
      value
      221
    units
    Participants
description
PFS defined as time from first day of therapy to first evidence of disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause. Progressive Disease (PD) is at least 20% increase in sum of diameters of target lesions, with reference being the smallest sum on study and plus absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If participant does not have complete baseline disease assessment, then PFS time was censored at date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for participant. If participant is not known to have died or have objective progression as of data inclusion cutoff date for analysis, PFS time was censored at last adequate tumor assessment date.
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
The first randomized participants. Censored participants: Ramucirumab + Docetaxel = 58, Placebo + Docetaxel =38.
reporting Status
POSTED
time Frame
Randomization to Radiological Disease Progression or Death from Any Cause (Up to 18 Months)
title
Progression Free Survival (PFS)
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice