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NCT02256436 · OUTCOME

Overall Survival (OS) - All Participants

A Study of Pembrolizumab (MK-3475) Versus Paclitaxel, Docetaxel, or Vinflunine for Participants With Advanced Urothelial Cancer (MK-3475-045/KEYNOTE-045) · Source last updated 2021-09-20

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
Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months)

What was measured

OS was defined as the time from randomization to death due to any cause. The OS was assessed in all participants up through the primary analysis database cut-off date of 07-Sep-2016.

Analysis population: The analysis population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.

Groups in this outcome

Control

Participants received paclitaxel 175 mg/m\^2 intravenously (IV) or docetaxel 75 mg/m\^2 IV or vinflunine 320 mg/m\^2 IV, on Day 1 of each 3-week cycle (Q3W). Eligible participants who experienced disease progression may have been able to switch over to receive pembrolizumab 200 mg IV Q3W for up to 35 treatment administrations (up to approximately 2 years).

Pembrolizumab

Participants received pembrolizumab 200 mg IV on Day 1 Q3W. Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg IV Q3W for up to 17 cycles (up to approximately 1 additional year).

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

Analysis denominator · Participants

GroupSource count
Control272
Pembrolizumab270

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Control7.45.16.18.3Not reported
Pembrolizumab10.337.88.011.8Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.59
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.91
    group Description
    OS - All Participants (Note: ECOG PS=Eastern Cooperative Oncology Group Performance Status)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.00224
    p Value Comment
    One-sided p-value based on stratified log-rank test
    param Type
    Hazard Ratio (HR)
    param Value
    0.73
    statistical Comment
    Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Lower Limit
    0.59
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.91
    group Description
    OS - All Participants (Note: ECOG PS=Eastern Cooperative Oncology Group Performance Status)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.00224
    p Value Comment
    One-sided p-value based on stratified log-rank test
    param Type
    Hazard Ratio (HR)
    param Value
    0.73
    statistical Comment
    Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.1
        spread
        5.1
        upper Limit
        8.3
        value
        7.4
      2. group Id
        OG001
        lower Limit
        8.0
        spread
        37.8
        upper Limit
        11.8
        value
        10.3
denoms
  1. counts
    1. group Id
      OG000
      value
      272
    2. group Id
      OG001
      value
      270
    units
    Participants
description
OS was defined as the time from randomization to death due to any cause. The OS was assessed in all participants up through the primary analysis database cut-off date of 07-Sep-2016.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received paclitaxel 175 mg/m\^2 intravenously (IV) or docetaxel 75 mg/m\^2 IV or vinflunine 320 mg/m\^2 IV, on Day 1 of each 3-week cycle (Q3W). Eligible participants who experienced disease progression may have been able to switch over to receive pembrolizumab 200 mg IV Q3W for up to 35 treatment administrations (up to approximately 2 years).
    id
    OG000
    title
    Control
  2. description
    Participants received pembrolizumab 200 mg IV on Day 1 Q3W. Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg IV Q3W for up to 17 cycles (up to approximately 1 additional year).
    id
    OG001
    title
    Pembrolizumab
param Type
MEDIAN
population Description
The analysis population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.
reporting Status
POSTED
time Frame
Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months)
title
Overall Survival (OS) - All Participants
type
PRIMARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice