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NCT01126749 · OUTCOME

Phase 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From the first dose of study drug up to approximately 6 years 3 months

What was measured

TEAE was defined as an adverse event that had an onset date, or a worsening in severity on or after the first dose of study drug up to the end of the study. Number of participants with TEAEs were reported based on safety assessments of laboratory tests, physical examination, examining bowel movements, regular measurement of vital signs, eastern cooperative oncology group-performance status and electrocardiogram parameter values. SAE was any untoward medical occurrence that at any dose: resulted in death; life threatening required inpatient hospitalization; resulted in persistent, significant disability; was congenital anomaly/birth defect or medically important due to other reasons than mentioned criteria. Number of participants with TEAEs and SAEs were reported.

Analysis population: SAS included all participants who were randomized and treated in Phase 2 of this study.

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^241
Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^239

Reported measurements

TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^241Not reportedNot reportedNot reportedNot reported
Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^238Not reportedNot reportedNot reportedNot reported
SAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^222Not reportedNot reportedNot reportedNot reported
Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^214Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        41
      2. group Id
        OG001
        value
        38
    title
    TEAEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        14
    title
    SAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      41
    2. group Id
      OG001
      value
      39
    units
    Participants
description
TEAE was defined as an adverse event that had an onset date, or a worsening in severity on or after the first dose of study drug up to the end of the study. Number of participants with TEAEs were reported based on safety assessments of laboratory tests, physical examination, examining bowel movements, regular measurement of vital signs, eastern cooperative oncology group-performance status and electrocardiogram parameter values. SAE was any untoward medical occurrence that at any dose: resulted in death; life threatening required inpatient hospitalization; resulted in persistent, significant disability; was congenital anomaly/birth defect or medically important due to other reasons than mentioned criteria. Number of participants with TEAEs and SAEs were reported.
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
COUNT_OF_PARTICIPANTS
population Description
SAS included all participants who were randomized and treated in Phase 2 of this study.
reporting Status
POSTED
time Frame
From the first dose of study drug up to approximately 6 years 3 months
title
Phase 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice