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NCT01761266 · OUTCOME

Percent Change From Baseline in Serum Biomarker

A Multicenter, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-line Treatment of Participants With Unresectable Hepatocellular Carcinoma · Source last updated 2022-04-05

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

Measure
MEDIAN
Unit
percent change
Interval / dispersion
Standard Deviation
Time frame
Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1, Cycle 8 Day 1, Cycle 9 Day 1 and at the Off-Treatment Visit (approximately up to 3.8 years)

What was measured

The serum biomarkers analysed were angiopoietin-2 (ANG2), fibroblast growth factor 19 (FGF19), fibroblast growth factor 21 (FGF21), fibroblast growth factor 23 (FGF23) and vascular endothelial growth factor (VEGF) as blood serum biomarkers, and protein induced by vitamin K absence or antagonist-II (PIVKA-II) as a blood tumor marker in serum. As planned, data for this pre-specified endpoint was collected and analyzed up to the primary completion date.

Analysis population: The pharmacodynamics (PD) analysis set included all participants who received at least 1 dose of study drug and had evaluable PD data. Here "n" was participants who were evaluable for the outcome measure at given time points.

Groups in this outcome

Lenvatinib

Subjects received lenvatinib capsules 12 milligram (mg) based on the participant's body weight greater than or equal to (\>=) 60 kilogram (kg) or 8 mg based on the subject's body weight less than (\<) 60 kg at baseline, orally, once daily (QD) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

Sorafenib

Participants received sorafenib 400 mg tablets, orally, twice daily (BID) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, 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
Lenvatinib66
Sorafenib48

Reported measurements

ANG 2: Cycle 1 Day 15
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib-28.115.9415.94Not reportedNot reported
Sorafenib8.923.9623.96Not reportedNot reported
ANG 2: Cycle 2 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib-28.816.5316.53Not reportedNot reported
Sorafenib-0.924.0624.06Not reportedNot reported
ANG 2: Cycle 3 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib-32.223.2323.23Not reportedNot reported
Sorafenib0.526.6226.62Not reportedNot reported
ANG 2: Cycle 4 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib-35.622.9122.91Not reportedNot reported
Sorafenib-4.520.0520.05Not reportedNot reported
ANG 2: Cycle 5 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib-38.919.8319.83Not reportedNot reported
Sorafenib7.023.2523.25Not reportedNot reported
ANG 2: Cycle 6 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib-36.723.5923.59Not reportedNot reported
Sorafenib-3.624.8224.82Not reportedNot reported
ANG 2: Cycle 7 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib-41.421.2021.20Not reportedNot reported
Sorafenib1.032.8332.83Not reportedNot reported
ANG 2: Cycle 8 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib-40.225.3325.33Not reportedNot reported
Sorafenib-6.731.2631.26Not reportedNot reported
ANG 2: Cycle 9 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib-39.614.0414.04Not reportedNot reported
Sorafenib-1.129.6829.68Not reportedNot reported
ANG 2: Off-Treatment
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib11.799.1399.13Not reportedNot reported
Sorafenib16.827.8827.88Not reportedNot reported
FGF19: Cycle 1 Day 15
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib75.0155.01155.01Not reportedNot reported
Sorafenib1.383.6583.65Not reportedNot reported
FGF19: Cycle 2 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib66.5134.26134.26Not reportedNot reported
Sorafenib36.6119.65119.65Not reportedNot reported
FGF19: Cycle 3 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib86.9123.85123.85Not reportedNot reported
Sorafenib22.870.5870.58Not reportedNot reported
FGF19: Cycle 4 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib208.1602.11602.11Not reportedNot reported
Sorafenib46.8214.14214.14Not reportedNot reported
FGF19: Cycle 5 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib152.8228.37228.37Not reportedNot reported
Sorafenib-1.040.3640.36Not reportedNot reported
FGF19: Cycle 6 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib119.8203.81203.81Not reportedNot reported
Sorafenib26.967.1367.13Not reportedNot reported
FGF19: Cycle 7 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib64.4101.97101.97Not reportedNot reported
Sorafenib-5.957.3957.39Not reportedNot reported
FGF19: Cycle 8 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib95.8135.31135.31Not reportedNot reported
Sorafenib53.9113.79113.79Not reportedNot reported
FGF19: Cycle 9 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib159.3202.00202.00Not reportedNot reported
Sorafenib56.6109.46109.46Not reportedNot reported
FGF19: Off-Treatment
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib140.1270.73270.73Not reportedNot reported
Sorafenib9.064.1764.17Not reportedNot reported
FGF 21: Cycle 1 Day 15
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib22.075.2275.22Not reportedNot reported
Sorafenib4.043.1443.14Not reportedNot reported
FGF 21: Cycle 2 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib15.777.4477.44Not reportedNot reported
Sorafenib18.657.1857.18Not reportedNot reported
FGF 21: Cycle 3 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib38.338.338.3Not reportedNot reported
Sorafenib49.476.4376.43Not reportedNot reported
FGF 21: Cycle 4 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib42.9145.43145.43Not reportedNot reported
Sorafenib32.870.6370.63Not reportedNot reported
FGF 21: Cycle 5 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib41.095.9795.97Not reportedNot reported
Sorafenib31.143.1543.15Not reportedNot reported
FGF 21: Cycle 6 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib52.6168.22168.22Not reportedNot reported
Sorafenib23.240.9040.90Not reportedNot reported
FGF 21: Cycle 7 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib63.4128.34128.34Not reportedNot reported
Sorafenib23.753.8453.84Not reportedNot reported
FGF 21 : Cycle 8 Day1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib38.3115.53115.53Not reportedNot reported
Sorafenib17.068.5168.51Not reportedNot reported
FGF 21: Cycle 9 Day1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib59.1108.39108.39Not reportedNot reported
Sorafenib68.9103.55103.55Not reportedNot reported
FGF 21: Off-Treatment
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib141.4340.51340.51Not reportedNot reported
Sorafenib104.9183.28183.28Not reportedNot reported
FGF 23: Cycle 1 Day15
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib23.949.0149.01Not reportedNot reported
Sorafenib-16.336.1436.14Not reportedNot reported
FGF 23: Cycle 2 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib20.956.9156.91Not reportedNot reported
Sorafenib-6.248.1848.18Not reportedNot reported
FGF 23: Cycle 3 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib25.545.2745.27Not reportedNot reported
Sorafenib17.375.2575.25Not reportedNot reported
FGF 23: Cycle 4 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib29.548.3848.38Not reportedNot reported
Sorafenib14.249.2949.29Not reportedNot reported
FGF 23: Cycle 5 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib29.663.6963.69Not reportedNot reported
Sorafenib1.047.2847.28Not reportedNot reported
FGF 23: Cycle 6 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib26.354.5754.57Not reportedNot reported
Sorafenib-10.646.1546.15Not reportedNot reported
FGF 23: Cycle 7 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib31.557.4457.44Not reportedNot reported
Sorafenib0.746.9546.95Not reportedNot reported
FGF 23: Cycle 8 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib38.167.3567.35Not reportedNot reported
Sorafenib2.843.8443.84Not reportedNot reported
FGF 23: Cycle 9 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib23.262.5862.58Not reportedNot reported
Sorafenib0.538.7438.74Not reportedNot reported
FGF 23: Off-Treatment
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib17.873.5973.59Not reportedNot reported
Sorafenib14.247.1147.11Not reportedNot reported
PIVKA-II: Cycle 1 Day 15
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib80.0171.41171.41Not reportedNot reported
Sorafenib166.9256.04256.04Not reportedNot reported
PIVKA-II: Cycle 2 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib169.7329.33329.33Not reportedNot reported
Sorafenib243.8416.82416.82Not reportedNot reported
PIVKA-II: Cycle 3 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib252.4611.40611.40Not reportedNot reported
Sorafenib218.7281.45281.45Not reportedNot reported
PIVKA-II: Cycle 4 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib371.7812.45812.45Not reportedNot reported
Sorafenib196.2348.80348.80Not reportedNot reported
PIVKA-II: Cycle 5 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib628.21752.641752.64Not reportedNot reported
Sorafenib369.5766.59766.59Not reportedNot reported
PIVKA-II: Cycle 6 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib648.72746.412746.41Not reportedNot reported
Sorafenib415.7554.27554.27Not reportedNot reported
PIVKA-II: Cycle 7 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib184.8352.75352.75Not reportedNot reported
Sorafenib703.61226.581226.58Not reportedNot reported
PIVKA-II: Cycle 8 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib277.8481.53481.53Not reportedNot reported
Sorafenib724.01257.871257.87Not reportedNot reported
PIVKA-II: Cycle 9 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib318.8577.21577.21Not reportedNot reported
Sorafenib859.11492.931492.93Not reportedNot reported
PIVKA-II: Off-Treatment
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib809.31827.421827.42Not reportedNot reported
Sorafenib272.5489.60489.60Not reportedNot reported
VEGF: Cycle 1 Day 15
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib157.5300.21300.21Not reportedNot reported
Sorafenib97.4118.43118.43Not reportedNot reported
VEGF: Cycle 2 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib128.9333.85333.85Not reportedNot reported
Sorafenib94.0180.80180.80Not reportedNot reported
VEGF: Cycle 3 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib97.7162.39162.39Not reportedNot reported
Sorafenib66.0124.58124.58Not reportedNot reported
VEGF: Cycle 4 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib113.4231.19231.19Not reportedNot reported
Sorafenib76.1111.20111.20Not reportedNot reported
VEGF: Cycle 5 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib132.4249.59249.59Not reportedNot reported
Sorafenib116.2215.57215.57Not reportedNot reported
VEGF: Cycle 6 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib113.1219.36219.36Not reportedNot reported
Sorafenib130.9341.12341.12Not reportedNot reported
VEGF: Cycle 7 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib133.1383.43383.43Not reportedNot reported
Sorafenib96.9173.77173.77Not reportedNot reported
VEGF: Cycle 8 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib148.7349.58349.58Not reportedNot reported
Sorafenib181.1399.67399.67Not reportedNot reported
VEGF: Cycle 9 Day 1
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib129.6215.05215.05Not reportedNot reported
Sorafenib135.6267.61267.61Not reportedNot reported
VEGF: Off-Treatment
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenvatinib127.1266.64266.64Not reportedNot reported
Sorafenib147.8304.31304.31Not reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.94
        spread
        15.94
        value
        -28.1
      2. group Id
        OG001
        lower Limit
        23.96
        spread
        23.96
        value
        8.9
    title
    ANG 2: Cycle 1 Day 15
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16.53
        spread
        16.53
        value
        -28.8
      2. group Id
        OG001
        lower Limit
        24.06
        spread
        24.06
        value
        -0.9
    title
    ANG 2: Cycle 2 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        23.23
        spread
        23.23
        value
        -32.2
      2. group Id
        OG001
        lower Limit
        26.62
        spread
        26.62
        value
        0.5
    title
    ANG 2: Cycle 3 Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22.91
        spread
        22.91
        value
        -35.6
      2. group Id
        OG001
        lower Limit
        20.05
        spread
        20.05
        value
        -4.5
    title
    ANG 2: Cycle 4 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        19.83
        spread
        19.83
        value
        -38.9
      2. group Id
        OG001
        lower Limit
        23.25
        spread
        23.25
        value
        7.0
    title
    ANG 2: Cycle 5 Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        23.59
        spread
        23.59
        value
        -36.7
      2. group Id
        OG001
        lower Limit
        24.82
        spread
        24.82
        value
        -3.6
    title
    ANG 2: Cycle 6 Day 1
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        21.20
        spread
        21.20
        value
        -41.4
      2. group Id
        OG001
        lower Limit
        32.83
        spread
        32.83
        value
        1.0
    title
    ANG 2: Cycle 7 Day 1
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        25.33
        spread
        25.33
        value
        -40.2
      2. group Id
        OG001
        lower Limit
        31.26
        spread
        31.26
        value
        -6.7
    title
    ANG 2: Cycle 8 Day 1
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        14.04
        spread
        14.04
        value
        -39.6
      2. group Id
        OG001
        lower Limit
        29.68
        spread
        29.68
        value
        -1.1
    title
    ANG 2: Cycle 9 Day 1
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        99.13
        spread
        99.13
        value
        11.7
      2. group Id
        OG001
        lower Limit
        27.88
        spread
        27.88
        value
        16.8
    title
    ANG 2: Off-Treatment
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        155.01
        spread
        155.01
        value
        75.0
      2. group Id
        OG001
        lower Limit
        83.65
        spread
        83.65
        value
        1.3
    title
    FGF19: Cycle 1 Day 15
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        134.26
        spread
        134.26
        value
        66.5
      2. group Id
        OG001
        lower Limit
        119.65
        spread
        119.65
        value
        36.6
    title
    FGF19: Cycle 2 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      66
    2. group Id
      OG001
      value
      48
    units
    Participants
description
The serum biomarkers analysed were angiopoietin-2 (ANG2), fibroblast growth factor 19 (FGF19), fibroblast growth factor 21 (FGF21), fibroblast growth factor 23 (FGF23) and vascular endothelial growth factor (VEGF) as blood serum biomarkers, and protein induced by vitamin K absence or antagonist-II (PIVKA-II) as a blood tumor marker in serum. As planned, data for this pre-specified endpoint was collected and analyzed up to the primary completion date.
dispersion Type
Standard Deviation
groups
  1. description
    Subjects received lenvatinib capsules 12 milligram (mg) based on the participant's body weight greater than or equal to (\>=) 60 kilogram (kg) or 8 mg based on the subject's body weight less than (\<) 60 kg at baseline, orally, once daily (QD) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
    id
    OG000
    title
    Lenvatinib
  2. description
    Participants received sorafenib 400 mg tablets, orally, twice daily (BID) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
    id
    OG001
    title
    Sorafenib
param Type
MEDIAN
population Description
The pharmacodynamics (PD) analysis set included all participants who received at least 1 dose of study drug and had evaluable PD data. Here "n" was participants who were evaluable for the outcome measure at given time points.
reporting Status
POSTED
time Frame
Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1, Cycle 8 Day 1, Cycle 9 Day 1 and at the Off-Treatment Visit (approximately up to 3.8 years)
title
Percent Change From Baseline in Serum Biomarker
type
OTHER_PRE_SPECIFIED
unit Of Measure
percent change

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