Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03690388 · OUTCOME

Progression Free Survival (PFS)

A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy · Source last updated 2025-09-25

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

Measure
MEDIAN
Unit
months
Interval / dispersion
96% Confidence Interval
Time frame
Up to approximately twenty months after the first subject is randomized. Time from randomization to the earlier of the following events: radiographic PD as determined by the blinded independent central review (BIRC) or death due to any cause.

What was measured

Time to the earlier of either radiographic progressive disease (PD) or death from any cause.

Analysis population: All subjects randomized at the time of the analysis (N=187).

Groups in this outcome

Cabozantinib

cabozantinib (60 mg) once daily orally (qd) Cabozantinib: Tablets containing 60-mg or 20-mg cabozantinib once daily orally.

Placebo

placebo once daily orally (qd) Placebo: Tablets containing placebo equivalent of 60-mg or 20-mg cabozantinib once daily orally.

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

Analysis denominator · Participants

GroupSource count
Cabozantinib125
Placebo62

Reported measurements

Source class 1
Values in months · Interval/dispersion: 96% Confidence Interval
GroupValueSpreadLowerUpperComment
CabozantinibNANot reported5.7NAThe CI 5.7 to 0.0 is not 0.0 but NA. The median PFS and upper bound of the CI could not be determined because not enough subjects on the cabozantinib arm had experienced progression at the time of the data cut-off to determine a median PFS. However, it was possible to estimate the HR at that timepoint based on the Cox Proportional Hazards Model.
Placebo1.9Not reported1.83.6Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.13
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    96
    ci Upper Limit
    0.36
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.22
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.13
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    96
    ci Upper Limit
    0.36
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.22
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        The CI 5.7 to 0.0 is not 0.0 but NA. The median PFS and upper bound of the CI could not be determined because not enough subjects on the cabozantinib arm had experienced progression at the time of the data cut-off to determine a median PFS. However, it was possible to estimate the HR at that timepoint based on the Cox Proportional Hazards Model.
        group Id
        OG000
        lower Limit
        5.7
        upper Limit
        NA
        value
        NA
      2. group Id
        OG001
        lower Limit
        1.8
        upper Limit
        3.6
        value
        1.9
denoms
  1. counts
    1. group Id
      OG000
      value
      125
    2. group Id
      OG001
      value
      62
    units
    Participants
description
Time to the earlier of either radiographic progressive disease (PD) or death from any cause.
dispersion Type
96% Confidence Interval
groups
  1. description
    cabozantinib (60 mg) once daily orally (qd) Cabozantinib: Tablets containing 60-mg or 20-mg cabozantinib once daily orally.
    id
    OG000
    title
    Cabozantinib
  2. description
    placebo once daily orally (qd) Placebo: Tablets containing placebo equivalent of 60-mg or 20-mg cabozantinib once daily orally.
    id
    OG001
    title
    Placebo
param Type
MEDIAN
population Description
All subjects randomized at the time of the analysis (N=187).
reporting Status
POSTED
time Frame
Up to approximately twenty months after the first subject is randomized. Time from randomization to the earlier of the following events: radiographic PD as determined by the blinded independent central review (BIRC) or death due to any cause.
title
Progression Free Survival (PFS)
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice