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NCT01321554 · OUTCOME

Progression Free Survival (PFS)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer (DTC) · Source last updated 2023-06-22

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
Date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years

What was measured

PFS was defined as the time from the date of randomization to the date of first documentation of disease progression or death (whichever occurred first), as determined by blinded IIR using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for the double-blind treatment period (Randomization Phase). Disease progression per RECIST v1.1 was defined as at least a 20 percent (%) relative increase and 5 millimeter (mm) absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), recorded since the treatment started or the appearance of 1 or more new lesions.

Analysis population: The full analysis set (Intent-to-Treat Analysis Set) included all randomized participants.

Groups in this outcome

Randomization Phase: Lenvatinib 24 mg

Participants received lenvatinib 24 mg, hard capsule, orally, once daily, until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.

Randomization Phase: Placebo

Participants received matching-placebo, hard capsule, orally, once daily until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.

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

Analysis denominator · Participants

GroupSource count
Randomization Phase: Lenvatinib 24 mg261
Randomization Phase: Placebo131

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomization Phase: Lenvatinib 24 mg18.3Not reported15.1NAThe upper limit of the 95% confidence interval was not estimable because an insufficient number of participants reached the event at the final assessment time point.
Randomization Phase: Placebo3.6Not reported2.23.7Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.14
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    99
    ci Upper Limit
    0.31
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Cox Proportional Hazard
    param Value
    0.21
Complete source fields
analyses
  1. ci Lower Limit
    0.14
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    99
    ci Upper Limit
    0.31
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Cox Proportional Hazard
    param Value
    0.21
classes
  1. categories
    1. measurements
      1. comment
        The upper limit of the 95% confidence interval was not estimable because an insufficient number of participants reached the event at the final assessment time point.
        group Id
        OG000
        lower Limit
        15.1
        upper Limit
        NA
        value
        18.3
      2. group Id
        OG001
        lower Limit
        2.2
        upper Limit
        3.7
        value
        3.6
denoms
  1. counts
    1. group Id
      OG000
      value
      261
    2. group Id
      OG001
      value
      131
    units
    Participants
description
PFS was defined as the time from the date of randomization to the date of first documentation of disease progression or death (whichever occurred first), as determined by blinded IIR using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for the double-blind treatment period (Randomization Phase). Disease progression per RECIST v1.1 was defined as at least a 20 percent (%) relative increase and 5 millimeter (mm) absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), recorded since the treatment started or the appearance of 1 or more new lesions.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received lenvatinib 24 mg, hard capsule, orally, once daily, until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
    id
    OG000
    title
    Randomization Phase: Lenvatinib 24 mg
  2. description
    Participants received matching-placebo, hard capsule, orally, once daily until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
    id
    OG001
    title
    Randomization Phase: Placebo
param Type
MEDIAN
population Description
The full analysis set (Intent-to-Treat Analysis Set) included all randomized participants.
reporting Status
POSTED
time Frame
Date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years
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