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NCT01721772 · OUTCOME

Overall Survival (OS) Extended

Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma · Source last updated 2022-07-12

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
From date of randomization to date of death. For those without documentation of death, to the last date the participant was known to be alive, assessed up to 94 months.

What was measured

OS is defined as the time between the date of randomization and the date of death. For those without documentation of death, OS will be censored on the last date the participant was known to be alive. OS data for this endpoint was collected after the primary completion date up until study completion.

Analysis population: All randomized participants

Groups in this outcome

Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine

Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion

Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab

Participants received dacarbazine 1000 mg/m\^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion

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

Analysis denominator · Participants

GroupSource count
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine210
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab208

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine37.29Not reported25.4051.55Not reported
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab11.17Not reported9.5612.98Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.41
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.65
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.51
Complete source fields
analyses
  1. ci Lower Limit
    0.41
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.65
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.51
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        25.40
        upper Limit
        51.55
        value
        37.29
      2. group Id
        OG001
        lower Limit
        9.56
        upper Limit
        12.98
        value
        11.17
denoms
  1. counts
    1. group Id
      OG000
      value
      210
    2. group Id
      OG001
      value
      208
    units
    Participants
description
OS is defined as the time between the date of randomization and the date of death. For those without documentation of death, OS will be censored on the last date the participant was known to be alive. OS data for this endpoint was collected after the primary completion date up until study completion.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
    id
    OG000
    title
    Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine
  2. description
    Participants received dacarbazine 1000 mg/m\^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
    id
    OG001
    title
    Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab
param Type
MEDIAN
population Description
All randomized participants
reporting Status
POSTED
time Frame
From date of randomization to date of death. For those without documentation of death, to the last date the participant was known to be alive, assessed up to 94 months.
title
Overall Survival (OS) Extended
type
POST_HOC
unit Of Measure
Months

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

Preserved source evidence · Not medical advice