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NCT02178241 · OUTCOME

Progression-free Survival

Gemcitabine Hydrochloride and Eribulin Mesylate in Treating Patients With Bladder Cancer That is Advanced or Cannot Be Removed by Surgery · Source last updated 2019-12-16

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 the start until progression, death, or the start of another treatment, assessed up to 12 months

What was measured

Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), 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.

Groups in this outcome

Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)

Patients receive 1000mg/m\^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 1.4mg/m\^2 eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Eribulin Mesylate: Given IV Gemcitabine Hydrochloride: Given IV

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

Analysis denominator · Participants

GroupSource count
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)24

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)5.3Not reported4.56.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.5
        upper Limit
        6.7
        value
        5.3
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    units
    Participants
description
Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), 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.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive 1000mg/m\^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 1.4mg/m\^2 eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Eribulin Mesylate: Given IV Gemcitabine Hydrochloride: Given IV
    id
    OG000
    title
    Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)
param Type
MEDIAN
reporting Status
POSTED
time Frame
From the start until progression, death, or the start of another treatment, assessed up to 12 months
title
Progression-free Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice