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NCT01721772 · OUTCOME

Overall Survival (OS) Rate

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 6 months and or to 12 months

What was measured

OS rate is calculated as the percentage of participants alive at the indicated timepoints

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

At 6 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine84.1Not reported78.388.5Not reported
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab71.8Not reported64.977.6Not reported
At 12 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine72.9Not reported65.578.9Not reported
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab42.1Not reported33.050.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        78.3
        upper Limit
        88.5
        value
        84.1
      2. group Id
        OG001
        lower Limit
        64.9
        upper Limit
        77.6
        value
        71.8
    title
    At 6 months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        65.5
        upper Limit
        78.9
        value
        72.9
      2. group Id
        OG001
        lower Limit
        33.0
        upper Limit
        50.9
        value
        42.1
    title
    At 12 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
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 6 months and or to 12 months
title
Overall Survival (OS) Rate
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice