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NCT00022633 · OUTCOME

Overall Confirmed Response Rate in the Patients Age 70 and Older (Complete and Partial Response)

S0028, Gemcitabine and Paclitaxel in Treating Patients With Advanced or Recurrent Cancer of the Urinary Tract · Source last updated 2016-08-11

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
every week for the first 4 weeks and then every 3 weeks for up to 19 weeks

What was measured

Complete response (CR) is defined as complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Partial response (PR) applies only to patients with least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions.

Analysis population: Eligible patients aged 70 years and older who had received any treatment were included in the analysis. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.

Groups in this outcome

Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)

Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)

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

Analysis denominator · Participants

GroupSource count
Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)51

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)22Not reported1135Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11
        upper Limit
        35
        value
        22
denoms
  1. counts
    1. group Id
      OG000
      value
      51
    units
    Participants
description
Complete response (CR) is defined as complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Partial response (PR) applies only to patients with least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
    id
    OG000
    title
    Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)
param Type
NUMBER
population Description
Eligible patients aged 70 years and older who had received any treatment were included in the analysis. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.
reporting Status
POSTED
time Frame
every week for the first 4 weeks and then every 3 weeks for up to 19 weeks
title
Overall Confirmed Response Rate in the Patients Age 70 and Older (Complete and Partial Response)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice