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NCT00112905 · OUTCOME

Best Overall Response by RECIST

Sorafenib in Treating Patients With Regional or Metastatic Cancer of the Urothelium · Source last updated 2014-05-30

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
Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 1 year.

What was measured

This outcome measure reports the best response a patient has ever experienced. \<Target Lesions\> Complete Response (CR): The disappearance of all target lesions, confirmed by assessments \>=4 weeks (wks) later. Partial Response: \>=30% decrease in the sum of the longest diameters of target lesions from baseline, confirmed by assessments \>=4 wks later. Progressive Disease (PD): \>=20% increase in the sum of the longest diameters of target lesions from the smallest sum longest diameter since baseline, or the appearance of new lesions. Stable Disease (SD): Neither response criteria nor progressive disease criteria are met for \>=8 wks. \<Nontarget Lesions\> CR: The disappearance of all nontarget lesions and normalization of tumor marker levels, confirmed by assessments \>=4 wks later. SD: Persistence of nontarget lesions or maintenance of tumor marker levels above the normal limits for \>=8 wks. PD: The appearance of new lesions or unequivocal progression of existing lesions.

Analysis population: Only eligible and treated patients are included in the analysis.

Groups in this outcome

TCC Cohort

Only eligible and treated patients are included in the analysis. BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies.

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

Analysis denominator · Participants

GroupSource count
TCC Cohort22

Reported measurements

Complete response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TCC Cohort0Not reportedNot reportedNot reportedNot reported
Partial response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TCC Cohort0Not reportedNot reportedNot reportedNot reported
Stable disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TCC Cohort3Not reportedNot reportedNot reportedNot reported
Progression
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TCC Cohort9Not reportedNot reportedNot reportedNot reported
Unevaluable
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TCC Cohort10Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Complete response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Partial response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Stable disease
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Progression
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    title
    Unevaluable
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    units
    Participants
description
This outcome measure reports the best response a patient has ever experienced. \<Target Lesions\> Complete Response (CR): The disappearance of all target lesions, confirmed by assessments \>=4 weeks (wks) later. Partial Response: \>=30% decrease in the sum of the longest diameters of target lesions from baseline, confirmed by assessments \>=4 wks later. Progressive Disease (PD): \>=20% increase in the sum of the longest diameters of target lesions from the smallest sum longest diameter since baseline, or the appearance of new lesions. Stable Disease (SD): Neither response criteria nor progressive disease criteria are met for \>=8 wks. \<Nontarget Lesions\> CR: The disappearance of all nontarget lesions and normalization of tumor marker levels, confirmed by assessments \>=4 wks later. SD: Persistence of nontarget lesions or maintenance of tumor marker levels above the normal limits for \>=8 wks. PD: The appearance of new lesions or unequivocal progression of existing lesions.
groups
  1. description
    Only eligible and treated patients are included in the analysis. BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies.
    id
    OG000
    title
    TCC Cohort
param Type
NUMBER
population Description
Only eligible and treated patients are included in the analysis.
reporting Status
POSTED
time Frame
Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 1 year.
title
Best Overall Response by RECIST
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice