NCT02627963 · OUTCOME

Objective Response Rate (ORR)

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: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Every 8 weeks from date of randomization until disease progression (up to approximately 5 years)

What was measured

The ORR is defined as the percentage of participants who have at least a 30% reduction in the sum of diameters per RECIST (Version 1.1).

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

Group	Source count
Tivozanib Hydrochloride	175
Sorafenib	175

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Tivozanib Hydrochloride	31	Not reported	Not reported	Not reported	Not reported
Sorafenib	14	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
31
group Id
OG001
value
14

denoms

counts
group Id
OG000
value
175
group Id
OG001
value
175
units
Participants

description

The ORR is defined as the percentage of participants who have at least a 30% reduction in the sum of diameters per RECIST (Version 1.1).

groups

description
Participants randomized to this arm received the study drug, tivozanib hydrochloride.
id
OG000
title
Tivozanib Hydrochloride
description
Participants randomized to this arm received the comparator drug, sorafenib.
id
OG001
title
Sorafenib

param Type

COUNT_OF_PARTICIPANTS

population Description

ITT Population

reporting Status

POSTED

time Frame

Every 8 weeks from date of randomization until disease progression (up to approximately 5 years)

title

Objective Response Rate (ORR)

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice