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NCT02569242 · OUTCOME

Overall Survival

Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer · Source last updated 2022-07-06

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
("Date of death from any cause" - "Date of randomization" + 1) / 30.4375. For subjects lost to follow-up and subjects who are alive at the time of data cutoff date, data will be censored at the time the subject was last confirmed to be alive.

Groups in this outcome

Nivolumab Arm

Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Active Comparator Arm (Docetaxel/Paclitaxel)

Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends OR Paclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

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 Arm210
Active Comparator Arm (Docetaxel/Paclitaxel)209

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab Arm10.9Not reported9.213.3Not reported
Active Comparator Arm (Docetaxel/Paclitaxel)8.4Not reported7.29.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.2
        upper Limit
        13.3
        value
        10.9
      2. group Id
        OG001
        lower Limit
        7.2
        upper Limit
        9.9
        value
        8.4
denoms
  1. counts
    1. group Id
      OG000
      value
      210
    2. group Id
      OG001
      value
      209
    units
    Participants
dispersion Type
95% Confidence Interval
groups
  1. description
    Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
    id
    OG000
    title
    Nivolumab Arm
  2. description
    Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends OR Paclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
    id
    OG001
    title
    Active Comparator Arm (Docetaxel/Paclitaxel)
param Type
MEDIAN
reporting Status
POSTED
time Frame
("Date of death from any cause" - "Date of randomization" + 1) / 30.4375. For subjects lost to follow-up and subjects who are alive at the time of data cutoff date, data will be censored at the time the subject was last confirmed to be alive.
title
Overall Survival
type
PRIMARY
unit Of Measure
months

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Preserved source evidence · Not medical advice