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NCT02627963 · OUTCOME

Duration of Response (DOR)

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
Assessed every 8 weeks from date of randomization until date of progression (up to approximately 5 years)

What was measured

The DOR is defined as the time from the first documentation of objective tumor response to the first documentation of tumor progression per RECIST 1.1 or to 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 HydrochlorideNANot reported12.91NAThe median and upper limit of the 95% confidence interval were not calculable because an insufficient number of participants reached the event.
Sorafenib5.65Not reported5.55NAThe upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The median and upper limit of the 95% confidence interval were not calculable because an insufficient number of participants reached the event.
        group Id
        OG000
        lower Limit
        12.91
        upper Limit
        NA
        value
        NA
      2. comment
        The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event.
        group Id
        OG001
        lower Limit
        5.55
        upper Limit
        NA
        value
        5.65
denoms
  1. counts
    1. group Id
      OG000
      value
      175
    2. group Id
      OG001
      value
      175
    units
    Participants
description
The DOR is defined as the time from the first documentation of objective tumor response to the first documentation of tumor progression per RECIST 1.1 or to 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
Assessed every 8 weeks from date of randomization until date of progression (up to approximately 5 years)
title
Duration of Response (DOR)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice