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NCT00245102 · OUTCOME

Overall Response Rate Measured by Complete Response (CR) Rate and Partial Response (PR) Rate as Determined by RECIST

Sorafenib in Treating Patients With Metastatic, Locally Advanced, or Recurrent Sarcoma · Source last updated 2014-05-23

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Up to 4 weeks

What was measured

A 5% response rate is considered not promising, a 20% response rate is considered promising. For each stratum, the response rate will be estimated and a confidence interval will be constructed.

Groups in this outcome

Angiosarcoma

Sorafenib 400 mg PO BID

MPNST

Sorafenib 400 mg PO BID

Leiomyosarcoma

Sorafenib 400 mg PO BID

Undifferentiated Pleomorphic Sarcoma

Sorafenib 400 mg PO BID

Fibrosarcoma

Sorafenib 400 mg PO BID

Other Histology

Sorafenib 400 mg PO BID

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

Analysis denominator · Participants

GroupSource count
Angiosarcoma37
MPNST12
Leiomyosarcoma39
Undifferentiated Pleomorphic Sarcoma10
Fibrosarcoma5
Other Histology19

Reported measurements

Complete Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Angiosarcoma1Not reportedNot reportedNot reportedNot reported
MPNST0Not reportedNot reportedNot reportedNot reported
Leiomyosarcoma0Not reportedNot reportedNot reportedNot reported
Undifferentiated Pleomorphic Sarcoma0Not reportedNot reportedNot reportedNot reported
Fibrosarcoma0Not reportedNot reportedNot reportedNot reported
Other Histology0Not reportedNot reportedNot reportedNot reported
Partial Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Angiosarcoma4Not reportedNot reportedNot reportedNot reported
MPNST0Not reportedNot reportedNot reportedNot reported
Leiomyosarcoma1Not reportedNot reportedNot reportedNot reported
Undifferentiated Pleomorphic Sarcoma0Not reportedNot reportedNot reportedNot reported
Fibrosarcoma0Not reportedNot reportedNot reportedNot reported
Other Histology0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Partial Response
denoms
  1. counts
    1. group Id
      OG000
      value
      37
    2. group Id
      OG001
      value
      12
    3. group Id
      OG002
      value
      39
    4. group Id
      OG003
      value
      10
    5. group Id
      OG004
      value
      5
    6. group Id
      OG005
      value
      19
    units
    Participants
description
A 5% response rate is considered not promising, a 20% response rate is considered promising. For each stratum, the response rate will be estimated and a confidence interval will be constructed.
groups
  1. description
    Sorafenib 400 mg PO BID
    id
    OG000
    title
    Angiosarcoma
  2. description
    Sorafenib 400 mg PO BID
    id
    OG001
    title
    MPNST
  3. description
    Sorafenib 400 mg PO BID
    id
    OG002
    title
    Leiomyosarcoma
  4. description
    Sorafenib 400 mg PO BID
    id
    OG003
    title
    Undifferentiated Pleomorphic Sarcoma
  5. description
    Sorafenib 400 mg PO BID
    id
    OG004
    title
    Fibrosarcoma
  6. description
    Sorafenib 400 mg PO BID
    id
    OG005
    title
    Other Histology
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 4 weeks
title
Overall Response Rate Measured by Complete Response (CR) Rate and Partial Response (PR) Rate as Determined by RECIST
type
PRIMARY
unit Of Measure
participants

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Preserved source evidence · Not medical advice