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NCT00091572 · OUTCOME

Overall Survival

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
The final analysis was to be performed when at least 616 deaths had occurred.

What was measured

Overall Survival was defined as the time from the date of randomization to the date of death from any cause.

Analysis population: Intent to Treat Population

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
Temozolomide429
Dacarbazine430

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Temozolomide9.13Not reported8.119.89Not reported
Dacarbazine9.36Not reported8.2110.28Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.86
    ci Pct Value
    95
    ci Upper Limit
    1.17
    estimate Comment
    Temozolomide events (deaths) = 320. Dacarbazine events (deaths) = 325.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.9999
    param Type
    Hazard Ratio (HR)
    param Value
    1.00
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.86
    ci Pct Value
    95
    ci Upper Limit
    1.17
    estimate Comment
    Temozolomide events (deaths) = 320. Dacarbazine events (deaths) = 325.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.9999
    param Type
    Hazard Ratio (HR)
    param Value
    1.00
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.11
        upper Limit
        9.89
        value
        9.13
      2. group Id
        OG001
        lower Limit
        8.21
        upper Limit
        10.28
        value
        9.36
denoms
  1. counts
    1. group Id
      OG000
      value
      429
    2. group Id
      OG001
      value
      430
    units
    Participants
description
Overall Survival was defined as the time from the date of randomization to the date of death from any cause.
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
Intent to Treat Population
reporting Status
POSTED
time Frame
The final analysis was to be performed when at least 616 deaths had occurred.
title
Overall Survival
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice