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NCT01613768 · OUTCOME

Time to Progression

Eribulin Mesylate in Treating Patients With Recurrent or Metastatic Salivary Gland Cancer · Source last updated 2018-09-28

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

Measure
MEDIAN
Unit
Weeks
Interval / dispersion
Full Range
Time frame
From date of first study therapy until date of first documented disease progression or date of death from any cause, whichever occurred first, assessed up to 36 days post last dose of study therapy.

What was measured

Either 1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by either CT or MRI: Progressive Disease (PD), \> 20% increase in the sum of the longest diameter (SLD) target lesions taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 mm increase over the nadir; or 2. Radiographic progression per treating physician CT or MRI scan review.

Analysis population: All participants receiving at least 1 dose of study intervention and at least 1 assessment post-baseline. Does not include 7 patients taken off study before radiological progression: Toxicity = 3, Clinical PD = 4.

Groups in this outcome

Treatment (Eribulin Mesylate)

Eribulin mesylate (1.4 mg/m2) administered intravenously (IV) over 2-5 minutes on days 1 and 8 of a 21 day cycle. Courses repeat every 21 days in the absence of disease progression or unacceptable 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
Treatment (Eribulin Mesylate)22

Reported measurements

Source class 1
Values in Weeks · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Treatment (Eribulin Mesylate)18.0Not reported5.7110.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.7
        upper Limit
        110.9
        value
        18.0
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    units
    Participants
description
Either 1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by either CT or MRI: Progressive Disease (PD), \> 20% increase in the sum of the longest diameter (SLD) target lesions taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 mm increase over the nadir; or 2. Radiographic progression per treating physician CT or MRI scan review.
dispersion Type
Full Range
groups
  1. description
    Eribulin mesylate (1.4 mg/m2) administered intravenously (IV) over 2-5 minutes on days 1 and 8 of a 21 day cycle. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Treatment (Eribulin Mesylate)
param Type
MEDIAN
population Description
All participants receiving at least 1 dose of study intervention and at least 1 assessment post-baseline. Does not include 7 patients taken off study before radiological progression: Toxicity = 3, Clinical PD = 4.
reporting Status
POSTED
time Frame
From date of first study therapy until date of first documented disease progression or date of death from any cause, whichever occurred first, assessed up to 36 days post last dose of study therapy.
title
Time to Progression
type
SECONDARY
unit Of Measure
Weeks

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

Preserved source evidence · Not medical advice