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NCT00949325 · OUTCOME

Median Progression-free Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2

Safety and Efficacy Study of Torisel and Liposomal Doxorubicin for Patients With Recurrent Sarcoma · Source last updated 2019-03-11

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

Measure
MEDIAN
Unit
days
Interval / dispersion
Full Range
Time frame
up to 3 years

What was measured

Interval from Date of start of treatment to date of disease progression or death from any cause. Disease progression is defined as at least 20% increase in sum of longest diameter of target lesions or appearance of any new lesions. Subjective determination of significant worsening of disease-related symptoms was considered clinical disease progression.

Analysis population: The number of analyzed participants does not include the 2 participants treated at the MTD who stopped treatment for early disease-related adverse events.

Groups in this outcome

Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2

Subjects who received Temsirolimus MTD, 20 mg/m\^2 in Phase I of the study and all subjects in the Phase II study were included from both Phase I and Phase II of the study who were not taken off study for early toxicity were included. Two of the eighteen subjects who were treated at the MTD were excluded.

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

Analysis denominator · Participants

GroupSource count
Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^216

Reported measurements

Source class 1
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^274Not reported7797Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7
        upper Limit
        797
        value
        74
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    units
    Participants
description
Interval from Date of start of treatment to date of disease progression or death from any cause. Disease progression is defined as at least 20% increase in sum of longest diameter of target lesions or appearance of any new lesions. Subjective determination of significant worsening of disease-related symptoms was considered clinical disease progression.
dispersion Type
Full Range
groups
  1. description
    Subjects who received Temsirolimus MTD, 20 mg/m\^2 in Phase I of the study and all subjects in the Phase II study were included from both Phase I and Phase II of the study who were not taken off study for early toxicity were included. Two of the eighteen subjects who were treated at the MTD were excluded.
    id
    OG000
    title
    Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2
param Type
MEDIAN
population Description
The number of analyzed participants does not include the 2 participants treated at the MTD who stopped treatment for early disease-related adverse events.
reporting Status
POSTED
time Frame
up to 3 years
title
Median Progression-free Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice