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NCT02387996 · OUTCOME

Progression Free Survival (PFS)

A Study of Nivolumab in Participants With Metastatic or Unresectable Bladder Cancer · Source last updated 2022-11-01

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
From first dosing date to the date of the first documented tumor progression (up to approximately 6 months)

What was measured

PFS was defined as the time from first dosing date to the date of the first documented tumor progression, based on Blinded Independent Review Committee (BIRC) assessments or death due to any cause. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. PD-L1 expression level is defined as membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells.

Analysis population: All treated participants

Groups in this outcome

Nivolumab 3 mg/kg

Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W

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

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg270

Reported measurements

All treated participants

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg270
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab 3 mg/kg1.94Not reported1.872.33Not reported
PD-L1 <1%

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg146
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab 3 mg/kg1.87Not reported1.742.00Not reported
PD-L1 >= 1%

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg124
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab 3 mg/kg3.45Not reported1.913.71Not reported
PD-L1 <5%

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg187
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab 3 mg/kg1.87Not reported1.812.04Not reported
PD-L1 >=5%

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg83
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab 3 mg/kg3.68Not reported1.915.52Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.87
        upper Limit
        2.33
        value
        1.94
    denoms
    1. counts
      1. group Id
        OG000
        value
        270
      units
      Participants
    title
    All treated participants
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.74
        upper Limit
        2.00
        value
        1.87
    denoms
    1. counts
      1. group Id
        OG000
        value
        146
      units
      Participants
    title
    PD-L1 <1%
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.91
        upper Limit
        3.71
        value
        3.45
    denoms
    1. counts
      1. group Id
        OG000
        value
        124
      units
      Participants
    title
    PD-L1 >= 1%
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.81
        upper Limit
        2.04
        value
        1.87
    denoms
    1. counts
      1. group Id
        OG000
        value
        187
      units
      Participants
    title
    PD-L1 <5%
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.91
        upper Limit
        5.52
        value
        3.68
    denoms
    1. counts
      1. group Id
        OG000
        value
        83
      units
      Participants
    title
    PD-L1 >=5%
denoms
  1. counts
    1. group Id
      OG000
      value
      270
    units
    Participants
description
PFS was defined as the time from first dosing date to the date of the first documented tumor progression, based on Blinded Independent Review Committee (BIRC) assessments or death due to any cause. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. PD-L1 expression level is defined as membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells.
dispersion Type
95% Confidence Interval
groups
  1. description
    Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
    id
    OG000
    title
    Nivolumab 3 mg/kg
param Type
MEDIAN
population Description
All treated participants
reporting Status
POSTED
time Frame
From first dosing date to the date of the first documented tumor progression (up to approximately 6 months)
title
Progression Free Survival (PFS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice