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NCT00478361 · OUTCOME

Safety and Efficacy of Same-day Pegfilgrastim

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
participants
Interval / dispersion
Not reported
Time frame
Up to 3 years

What was measured

Determined the number of participants who had either a fever due to abnormally low level of neutrophils, a type of white blood cell, on the day of study drug treatment, or the participants who had the study drug treatment delayed due to an abnormally low level of neutrophils.

Analysis population: Thirty-two patients (82%) received Pegfilgrastim immediately after chemotherapy on day 1 of the cycle.

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 Doxorubicin32

Reported measurements

Neutropenic Fever
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Paclitaxel and Doxorubicin4Not reportedNot reportedNot reportedNot reported
Treatment Delay
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Paclitaxel and Doxorubicin0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Neutropenic Fever
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Treatment Delay
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    units
    Participants
description
Determined the number of participants who had either a fever due to abnormally low level of neutrophils, a type of white blood cell, on the day of study drug treatment, or the participants who had the study drug treatment delayed due to an abnormally low level of neutrophils.
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
population Description
Thirty-two patients (82%) received Pegfilgrastim immediately after chemotherapy on day 1 of the cycle.
reporting Status
POSTED
time Frame
Up to 3 years
title
Safety and Efficacy of Same-day Pegfilgrastim
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice