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NCT00091572 · OUTCOME

Duration of Objective Response

Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267) · Source last updated 2017-06-06

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Treatment continued until disease progression or unacceptable toxicity.

What was measured

Duration of objective response was measured from the time the criteria were met for complete response or partial response to the first date that recurrent or progressive disease was objectively documented.

Analysis population: All responders

Groups in this outcome

Temozolomide

temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)

Dacarbazine

dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks

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

Analysis denominator · Participants

GroupSource count
Temozolomide55
Dacarbazine37

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Temozolomide4.34Not reported4.176.18Not reported
Dacarbazine8.31Not reported6.0819.25Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.17
        upper Limit
        6.18
        value
        4.34
      2. group Id
        OG001
        lower Limit
        6.08
        upper Limit
        19.25
        value
        8.31
denoms
  1. counts
    1. group Id
      OG000
      value
      55
    2. group Id
      OG001
      value
      37
    units
    Participants
description
Duration of objective response was measured from the time the criteria were met for complete response or partial response to the first date that recurrent or progressive disease was objectively documented.
dispersion Type
95% Confidence Interval
groups
  1. description
    temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)
    id
    OG000
    title
    Temozolomide
  2. description
    dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
    id
    OG001
    title
    Dacarbazine
param Type
MEDIAN
population Description
All responders
reporting Status
POSTED
time Frame
Treatment continued until disease progression or unacceptable toxicity.
title
Duration of Objective Response
type
SECONDARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice