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NCT02627963 · OUTCOME

Overall Survival (OS)

A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (RCC) · Source last updated 2023-07-18

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 randomization to date of death (up to approximately 5 years)

What was measured

The OS is defined as the time from the date of randomization to date of death due to any cause.

Analysis population: ITT Population

Groups in this outcome

Tivozanib Hydrochloride

Participants randomized to this arm received the study drug, tivozanib hydrochloride.

Sorafenib

Participants randomized to this arm received the comparator drug, sorafenib.

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

Analysis denominator · Participants

GroupSource count
Tivozanib Hydrochloride175
Sorafenib175

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Tivozanib Hydrochloride16.39Not reported13.4422.21Not reported
Sorafenib19.15Not reported14.9524.21Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.75
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.25
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.8174
    param Type
    Hazard Ratio (HR)
    param Value
    0.97
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.75
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.25
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.8174
    param Type
    Hazard Ratio (HR)
    param Value
    0.97
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        13.44
        upper Limit
        22.21
        value
        16.39
      2. group Id
        OG001
        lower Limit
        14.95
        upper Limit
        24.21
        value
        19.15
denoms
  1. counts
    1. group Id
      OG000
      value
      175
    2. group Id
      OG001
      value
      175
    units
    Participants
description
The OS is defined as the time from the date of randomization to date of death due to any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants randomized to this arm received the study drug, tivozanib hydrochloride.
    id
    OG000
    title
    Tivozanib Hydrochloride
  2. description
    Participants randomized to this arm received the comparator drug, sorafenib.
    id
    OG001
    title
    Sorafenib
param Type
MEDIAN
population Description
ITT Population
reporting Status
POSTED
time Frame
Date of randomization to date of death (up to approximately 5 years)
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice