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NCT02108652 · OUTCOME

Percentage of Participants With Death or Disease Progression as Assessed by the IRF According to RECIST v1.1

A Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer (Cohort 2) · Source last updated 2024-03-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)

What was measured

Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported.

Analysis population: Cohort 2 ITT population

Groups in this outcome

Cohort 2: Participants With Second-line or Beyond Treatments

Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.

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

Analysis denominator · Participants

GroupSource count
Cohort 2: Participants With Second-line or Beyond Treatments310

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 2: Participants With Second-line or Beyond Treatments88.4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        88.4
denoms
  1. counts
    1. group Id
      OG000
      value
      310
    units
    Participants
description
Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported.
groups
  1. description
    Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
    id
    OG000
    title
    Cohort 2: Participants With Second-line or Beyond Treatments
param Type
NUMBER
population Description
Cohort 2 ITT population
reporting Status
POSTED
time Frame
Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)
title
Percentage of Participants With Death or Disease Progression as Assessed by the IRF According to RECIST v1.1
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice