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NCT01126749 · OUTCOME

Phase 2: Overall Survival (OS)

Eribulin Mesylate Administered in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Alone as First-Line Therapy for Locally Advanced or Metastatic Bladder Cancer · Source last updated 2022-02-28

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

Measure
MEDIAN
Unit
weeks
Interval / dispersion
95% Confidence Interval
Time frame
From the date of randomization until the date of death (Up to approximately 6 years 3 months)

What was measured

OS was defined as the time from the date of randomization until the date of death due to any cause.

Analysis population: MITT analysis set included all participants who were randomized and received at least one dose of study medication without major protocol eligibility violations.

Groups in this outcome

Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2

Participants received Eribulin Mesylate 1.0 mg/m\^2 (Recommended Phase 2 dose), as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.

Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2

Participants received Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.

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

Analysis denominator · Participants

GroupSource count
Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^240
Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^239

Reported measurements

Source class 1
Values in weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^262.9Not reported39.86132.0Not reported
Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^264.6Not reported50.43126.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        39.86
        upper Limit
        132.0
        value
        62.9
      2. group Id
        OG001
        lower Limit
        50.43
        upper Limit
        126.4
        value
        64.6
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    2. group Id
      OG001
      value
      39
    units
    Participants
description
OS was defined as the time from the date of randomization until the date of death due to any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received Eribulin Mesylate 1.0 mg/m\^2 (Recommended Phase 2 dose), as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
    id
    OG000
    title
    Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2
  2. description
    Participants received Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
    id
    OG001
    title
    Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2
param Type
MEDIAN
population Description
MITT analysis set included all participants who were randomized and received at least one dose of study medication without major protocol eligibility violations.
reporting Status
POSTED
time Frame
From the date of randomization until the date of death (Up to approximately 6 years 3 months)
title
Phase 2: Overall Survival (OS)
type
SECONDARY
unit Of Measure
weeks

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

Preserved source evidence · Not medical advice