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NCT00478361 · OUTCOME

Objective Response Rate

Gemcitabine, Paclitaxel, Doxorubicin in Metastatic or Unresectable Bladder Cancer With Decreased Kidney Function · Source last updated 2020-10-09

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
Up to 12 weeks, or following completion 6 cycles of chemotherapy, respectively; the best response achieved within 6 cycles of starting chemotherapy used to calculate response rate.

What was measured

The percentage of participants with either Complete Response (CR) or Partial Response (PR) in their disease burden based upon the rules of the Response Evaluation Criteria in Solid Tumors (RECIST). A participant with of all of the lesions disappearing is a CR. A participant with at least a 30 percent decrease in the measured lesions is a PR.

Groups in this outcome

Gemcitabine, Paclitaxel and Doxorubicin

Paclitaxel 135 mg/m\^2 intravenous (IV) over 1 hour; Gemcitabine 900 mg/m\^2 IV over 90 minutes; Doxorubicin 40 mg/m\^2 IV over 20 minutes; treatment may repeat every 2 weeks for up to nine courses. Subcutaneous Injection of Pegfilgrastim on day 1 or 2 of each course, after chemotherapy.

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

Analysis denominator · Participants

GroupSource count
Gemcitabine, Paclitaxel and Doxorubicin39

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Gemcitabine, Paclitaxel and Doxorubicin56.4Not reported39.672.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        39.6
        upper Limit
        72.2
        value
        56.4
denoms
  1. counts
    1. group Id
      OG000
      value
      39
    units
    Participants
description
The percentage of participants with either Complete Response (CR) or Partial Response (PR) in their disease burden based upon the rules of the Response Evaluation Criteria in Solid Tumors (RECIST). A participant with of all of the lesions disappearing is a CR. A participant with at least a 30 percent decrease in the measured lesions is a PR.
dispersion Type
95% Confidence Interval
groups
  1. description
    Paclitaxel 135 mg/m\^2 intravenous (IV) over 1 hour; Gemcitabine 900 mg/m\^2 IV over 90 minutes; Doxorubicin 40 mg/m\^2 IV over 20 minutes; treatment may repeat every 2 weeks for up to nine courses. Subcutaneous Injection of Pegfilgrastim on day 1 or 2 of each course, after chemotherapy.
    id
    OG000
    title
    Gemcitabine, Paclitaxel and Doxorubicin
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 12 weeks, or following completion 6 cycles of chemotherapy, respectively; the best response achieved within 6 cycles of starting chemotherapy used to calculate response rate.
title
Objective Response Rate
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice