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NCT01808534 · OUTCOME

Overall Response Rate (Defined as Partial Response or Complete Response)

Palifosfamide in Treating Patients With Recurrent Germ Cell Tumors · Source last updated 2015-07-02

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 2 years

What was measured

The percent of patients who were shown as having a partial remission or better based on definitions of response in RECIST 1.1. At least a 30% decrease in the sum of the diameters of target lesions, in reference to baseline sum diameters, needs to be confirmed to be considered as partial response or better. Note: There were no patients with a partial or complete response.

Analysis population: All patients who enrolled and received treatment with at least one post baseline assessment.

Groups in this outcome

Treatment (Palifosfamide)

Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Treatment (Palifosfamide)5

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment (Palifosfamide)0Not reported00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
The percent of patients who were shown as having a partial remission or better based on definitions of response in RECIST 1.1. At least a 30% decrease in the sum of the diameters of target lesions, in reference to baseline sum diameters, needs to be confirmed to be considered as partial response or better. Note: There were no patients with a partial or complete response.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Treatment (Palifosfamide)
param Type
NUMBER
population Description
All patients who enrolled and received treatment with at least one post baseline assessment.
reporting Status
POSTED
time Frame
Up to 2 years
title
Overall Response Rate (Defined as Partial Response or Complete Response)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice