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NCT02576509 · OUTCOME

Overall Survival (OS)

An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma · Source last updated 2025-02-17

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
time from the date of randomization to the date of death due to any cause, assessed up to June 2019 (approximately 41 months)

What was measured

OS is defined as the time from the date of randomization to the date of death due to any cause in all randomized participants. Participants who are alive will be censored at the last known alive dates. Based on Kaplan-Meier Estimates.

Analysis population: all randomized participants

Groups in this outcome

Nivolumab 240 mg

Nivolumab 240 mg intravenously (IV) every 2 weeks until disease progression or unacceptable toxicity

Sorafenib 400 mg

Sorafenib 400 mg orally (PO) twice a day (BID) until disease progression or unacceptable toxicity

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 240 mg371
Sorafenib 400 mg372

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab 240 mg16.39Not reported13.9318.37Not reported
Sorafenib 400 mg14.69Not reported11.8917.22Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.71
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.02
    estimate Comment
    Nivolumab over Sorafenib; Stratified Cox proportional hazard model
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    95.81% CI ADJUSTED FOR MULTIPLICITY: (0.72 to 1.02)
    p Value
    0.0752
    p Value Comment
    A priori threshold for statistical significance is 0.0419
    param Type
    Hazard Ratio (HR)
    param Value
    0.85
    statistical Comment
    Log-rank Test stratified by the stratification factors as entered into the IVRS
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.71
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.02
    estimate Comment
    Nivolumab over Sorafenib; Stratified Cox proportional hazard model
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    95.81% CI ADJUSTED FOR MULTIPLICITY: (0.72 to 1.02)
    p Value
    0.0752
    p Value Comment
    A priori threshold for statistical significance is 0.0419
    param Type
    Hazard Ratio (HR)
    param Value
    0.85
    statistical Comment
    Log-rank Test stratified by the stratification factors as entered into the IVRS
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        13.93
        upper Limit
        18.37
        value
        16.39
      2. group Id
        OG001
        lower Limit
        11.89
        upper Limit
        17.22
        value
        14.69
denoms
  1. counts
    1. group Id
      OG000
      value
      371
    2. group Id
      OG001
      value
      372
    units
    Participants
description
OS is defined as the time from the date of randomization to the date of death due to any cause in all randomized participants. Participants who are alive will be censored at the last known alive dates. Based on Kaplan-Meier Estimates.
dispersion Type
95% Confidence Interval
groups
  1. description
    Nivolumab 240 mg intravenously (IV) every 2 weeks until disease progression or unacceptable toxicity
    id
    OG000
    title
    Nivolumab 240 mg
  2. description
    Sorafenib 400 mg orally (PO) twice a day (BID) until disease progression or unacceptable toxicity
    id
    OG001
    title
    Sorafenib 400 mg
param Type
MEDIAN
population Description
all randomized participants
reporting Status
POSTED
time Frame
time from the date of randomization to the date of death due to any cause, assessed up to June 2019 (approximately 41 months)
title
Overall Survival (OS)
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice