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NCT00400569 · OUTCOME

Participants' Progression Free Survival (PFS)

Phase II Study of Sunitinib Malate for Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma · Source last updated 2012-08-28

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 On Treatment to Off Study - average of 6 months

What was measured

Time to tumor progression defined as the duration of time from start of treatment to time of progression. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).

Analysis population: All participants who completed the study

Groups in this outcome

Liposarcoma Cohort Only

Experimental: Sunitinib Malate (SU011248) Treatment

Leiomyosarcoma Cohort Only

Experimental: Sunitinib Malate (SU011248) Treatment

Malignant Fibrous Histiocytoma (MFH) Cohort Only

Experimental: Sunitinib Malate (SU011248) Treatment

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

Analysis denominator · Participants

GroupSource count
Liposarcoma Cohort Only18
Leiomyosarcoma Cohort Only15
Malignant Fibrous Histiocytoma (MFH) Cohort Only14

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Liposarcoma Cohort Only3.9Not reported2.84.4Not reported
Leiomyosarcoma Cohort Only4.2Not reported2.08.3Not reported
Malignant Fibrous Histiocytoma (MFH) Cohort Only2.5Not reported1.45.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.8
        upper Limit
        4.4
        value
        3.9
      2. group Id
        OG001
        lower Limit
        2.0
        upper Limit
        8.3
        value
        4.2
      3. group Id
        OG002
        lower Limit
        1.4
        upper Limit
        5.5
        value
        2.5
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    2. group Id
      OG001
      value
      15
    3. group Id
      OG002
      value
      14
    units
    Participants
description
Time to tumor progression defined as the duration of time from start of treatment to time of progression. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).
dispersion Type
95% Confidence Interval
groups
  1. description
    Experimental: Sunitinib Malate (SU011248) Treatment
    id
    OG000
    title
    Liposarcoma Cohort Only
  2. description
    Experimental: Sunitinib Malate (SU011248) Treatment
    id
    OG001
    title
    Leiomyosarcoma Cohort Only
  3. description
    Experimental: Sunitinib Malate (SU011248) Treatment
    id
    OG002
    title
    Malignant Fibrous Histiocytoma (MFH) Cohort Only
param Type
MEDIAN
population Description
All participants who completed the study
reporting Status
POSTED
time Frame
From On Treatment to Off Study - average of 6 months
title
Participants' Progression Free Survival (PFS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice