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NCT01835158 · OUTCOME

Objective Response Rates

Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer · Source last updated 2021-02-11

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
proportion of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 5 years

What was measured

Objective response rates (ORR) was investigator assessed. ORR is the rate of complete or partial responses, based on RECIST 1.1 criteria. A response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. The Fisher exact test will be used to compare the two treatment arms.

Analysis population: All enrolled patients.

Groups in this outcome

Arm I (Cabozantinib-s-malate)

Patients receive 60mg cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Arm II (Sunitinib Malate)

Patients receive 50mg sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of 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
Arm I (Cabozantinib-s-malate)79
Arm II (Sunitinib Malate)78

Reported measurements

Source class 1
Values in proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Cabozantinib-s-malate)0.33Not reported0.230.44Not reported
Arm II (Sunitinib Malate)0.12Not reported0.0540.21Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.23
        upper Limit
        0.44
        value
        0.33
      2. group Id
        OG001
        lower Limit
        0.054
        upper Limit
        0.21
        value
        0.12
denoms
  1. counts
    1. group Id
      OG000
      value
      79
    2. group Id
      OG001
      value
      78
    units
    Participants
description
Objective response rates (ORR) was investigator assessed. ORR is the rate of complete or partial responses, based on RECIST 1.1 criteria. A response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. The Fisher exact test will be used to compare the two treatment arms.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive 60mg cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Arm I (Cabozantinib-s-malate)
  2. description
    Patients receive 50mg sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
    id
    OG001
    title
    Arm II (Sunitinib Malate)
param Type
NUMBER
population Description
All enrolled patients.
reporting Status
POSTED
time Frame
Up to 5 years
title
Objective Response Rates
type
SECONDARY
unit Of Measure
proportion of participants

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

Preserved source evidence · Not medical advice