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NCT00704730 · OUTCOME

Overall Survival (OS) With XL184 Compared With Placebo

Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer · Source last updated 2021-04-20

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
The pre-specified interim analysis of Overall Survival (OS) was assessed at 44% of required events. Includes data up to 15June2011. As of this date, the number of deaths required to conduct the primary analysis had not been reached.

What was measured

Duration of Overall Survival (OS) from the time of randomization to death due to any cause. A Kaplan-Meier analysis was performed to estimate the median.

Analysis population: Intent to treat (ITT) randomized to either XL184 or placebo

Groups in this outcome

XL184 (Cabozantinib)

XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily

Placebo

Oral capsules once daily

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

Analysis denominator · Participants

GroupSource count
XL184 (Cabozantinib)219
Placebo111

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
XL184 (Cabozantinib)21.1Not reported16.5928.52Not reported
PlaceboNANot reported17.41NAMedian duration OS could not be estimated for placebo at data cut-off June 15, 2011 due to insufficient number of participants with events. At time of analysis of PFS, number of deaths required to conduct primary analysis of OS was not reached.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16.59
        upper Limit
        28.52
        value
        21.1
      2. comment
        Median duration OS could not be estimated for placebo at data cut-off June 15, 2011 due to insufficient number of participants with events. At time of analysis of PFS, number of deaths required to conduct primary analysis of OS was not reached.
        group Id
        OG001
        lower Limit
        17.41
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      219
    2. group Id
      OG001
      value
      111
    units
    Participants
description
Duration of Overall Survival (OS) from the time of randomization to death due to any cause. A Kaplan-Meier analysis was performed to estimate the median.
dispersion Type
95% Confidence Interval
groups
  1. description
    XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
    id
    OG000
    title
    XL184 (Cabozantinib)
  2. description
    Oral capsules once daily
    id
    OG001
    title
    Placebo
param Type
MEDIAN
population Description
Intent to treat (ITT) randomized to either XL184 or placebo
reporting Status
POSTED
time Frame
The pre-specified interim analysis of Overall Survival (OS) was assessed at 44% of required events. Includes data up to 15June2011. As of this date, the number of deaths required to conduct the primary analysis had not been reached.
title
Overall Survival (OS) With XL184 Compared With Placebo
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice