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NCT01721772 · OUTCOME

Overall Survival (OS) Rate 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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From randomization to the specified timepoints, up to 84 months

What was measured

OS rate is calculated as the percentage of participants alive at the indicated timepoints. Data for this endpoint was collected after the primary completion date up until study completion. The OS rate for the 6 month and 12 month timepoints reflect updated data that was collected after the primary completion date.

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

6 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine48.2Not reported41.055.0Not reported
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab20.0Not reported14.626.1Not reported
12 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine43.3Not reported36.350.2Not reported
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab7.4Not reported3.912.4Not reported
18 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine63.8Not reported56.870.0Not reported
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab36.7Not reported30.043.3Not reported
24 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine57.8Not reported50.764.2Not reported
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab26.3Not reported20.432.6Not reported
36 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine50.8Not reported43.757.5Not reported
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab21.6Not reported16.127.6Not reported
48 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine43.8Not reported36.950.5Not reported
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab17.9Not reported12.923.6Not reported
60 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine39.3Not reported32.646.0Not reported
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab17.4Not reported12.423.0Not reported
72 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine37.3Not reported30.743.9Not reported
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab16.9Not reported12.022.5Not reported
84 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine36.2Not reported29.542.8Not reported
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab16.9Not reported12.022.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        41.0
        upper Limit
        55.0
        value
        48.2
      2. group Id
        OG001
        lower Limit
        14.6
        upper Limit
        26.1
        value
        20.0
    title
    6 months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        36.3
        upper Limit
        50.2
        value
        43.3
      2. group Id
        OG001
        lower Limit
        3.9
        upper Limit
        12.4
        value
        7.4
    title
    12 months
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        56.8
        upper Limit
        70.0
        value
        63.8
      2. group Id
        OG001
        lower Limit
        30.0
        upper Limit
        43.3
        value
        36.7
    title
    18 months
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        50.7
        upper Limit
        64.2
        value
        57.8
      2. group Id
        OG001
        lower Limit
        20.4
        upper Limit
        32.6
        value
        26.3
    title
    24 months
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        43.7
        upper Limit
        57.5
        value
        50.8
      2. group Id
        OG001
        lower Limit
        16.1
        upper Limit
        27.6
        value
        21.6
    title
    36 months
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        36.9
        upper Limit
        50.5
        value
        43.8
      2. group Id
        OG001
        lower Limit
        12.9
        upper Limit
        23.6
        value
        17.9
    title
    48 months
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        32.6
        upper Limit
        46.0
        value
        39.3
      2. group Id
        OG001
        lower Limit
        12.4
        upper Limit
        23.0
        value
        17.4
    title
    60 months
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        30.7
        upper Limit
        43.9
        value
        37.3
      2. group Id
        OG001
        lower Limit
        12.0
        upper Limit
        22.5
        value
        16.9
    title
    72 months
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        29.5
        upper Limit
        42.8
        value
        36.2
      2. group Id
        OG001
        lower Limit
        12.0
        upper Limit
        22.5
        value
        16.9
    title
    84 months
denoms
  1. counts
    1. group Id
      OG000
      value
      210
    2. group Id
      OG001
      value
      208
    units
    Participants
description
OS rate is calculated as the percentage of participants alive at the indicated timepoints. Data for this endpoint was collected after the primary completion date up until study completion. The OS rate for the 6 month and 12 month timepoints reflect updated data that was collected after the primary completion date.
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
NUMBER
population Description
All randomized participants
reporting Status
POSTED
time Frame
From randomization to the specified timepoints, up to 84 months
title
Overall Survival (OS) Rate Extended
type
POST_HOC
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice