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NCT04322539 · OUTCOME

Change From Baseline of Electrocardiogram (ECG) Results - QTcF Intervals Using Fridericia's Formula

A Study of Efficacy and Safety of Fruquintinib (HMPL-013) in Participants With Metastatic Colorectal Cancer · Source last updated 2025-04-04

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

Measure
MEAN
Unit
millisecond (msec)
Interval / dispersion
Standard Deviation
Time frame
Baseline, Cycle 1 (Day 1 and 21): Pre-dose, 1, 2, 3 and 4 hours; Cycle 2 and 3 (Day 21): Pre-dose (Each cycle = 28 days)

What was measured

QT Interval: Ventricular depolarization plus ventricular repolarization Normal Range: 400 to 460 milliseconds (msec). QTc: QT interval corrected based on the patient's heart rate. QTcF: An electrocardiographic finding in which the QT interval corrected for heart rate using Fridericia's formula. QTc = QT/∛(RR) RR = Respiration rate.

Analysis population: SP included all randomized participants who received at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at the specified time points.

Groups in this outcome

Fruquintinib + BSC Group

Participants received 5 mg of fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).

Placebo + BSC Group

Participants received placebo matched to fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).

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

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group272
Placebo + BSC Group131

Reported measurements

Cycle 1 Day 1 - Pre-dose

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group261
Placebo + BSC Group126
Values in millisecond (msec) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group1.921.33Not reportedNot reportedNot reported
Placebo + BSC Group0.117.95Not reportedNot reportedNot reported
Cycle 1 Day 1 - 1 hour

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group149
Placebo + BSC Group71
Values in millisecond (msec) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group-0.119.60Not reportedNot reportedNot reported
Placebo + BSC Group2.519.70Not reportedNot reportedNot reported
Cycle 1 Day 1 - 2 hours

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group272
Placebo + BSC Group131
Values in millisecond (msec) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group1.922.58Not reportedNot reportedNot reported
Placebo + BSC Group3.520.13Not reportedNot reportedNot reported
Cycle 1 Day 1 - 3 hours

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group143
Placebo + BSC Group70
Values in millisecond (msec) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group2.619.77Not reportedNot reportedNot reported
Placebo + BSC Group3.318.03Not reportedNot reportedNot reported
Cycle 1 Day 1 - 4 hours

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group136
Placebo + BSC Group67
Values in millisecond (msec) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group1.220.48Not reportedNot reportedNot reported
Placebo + BSC Group0.917.66Not reportedNot reportedNot reported
Cycle 1 Day 21 - Pre-dose

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group184
Placebo + BSC Group95
Values in millisecond (msec) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group3.220.94Not reportedNot reportedNot reported
Placebo + BSC Group-2.220.31Not reportedNot reportedNot reported
Cycle 1 Day 21 - 1 hour

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group109
Placebo + BSC Group62
Values in millisecond (msec) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group4.019.56Not reportedNot reportedNot reported
Placebo + BSC Group-0.216.77Not reportedNot reportedNot reported
Cycle 1 Day 21 - 2 hours

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group222
Placebo + BSC Group121
Values in millisecond (msec) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group5.020.06Not reportedNot reportedNot reported
Placebo + BSC Group2.818.23Not reportedNot reportedNot reported
Cycle 1 Day 21 - 3 hours

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group111
Placebo + BSC Group61
Values in millisecond (msec) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group5.919.46Not reportedNot reportedNot reported
Placebo + BSC Group0.214.70Not reportedNot reportedNot reported
Cycle 1 Day 21 - 4 hours

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group103
Placebo + BSC Group58
Values in millisecond (msec) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group3.920.98Not reportedNot reportedNot reported
Placebo + BSC Group-0.618.13Not reportedNot reportedNot reported
Cycle 2 Day 21 - 2 hours

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group229
Placebo + BSC Group86
Values in millisecond (msec) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group1.422.41Not reportedNot reportedNot reported
Placebo + BSC Group4.924.28Not reportedNot reportedNot reported
Cycle 3 Day 21 - 2 hours

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group141
Placebo + BSC Group28
Values in millisecond (msec) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group2.631.61Not reportedNot reportedNot reported
Placebo + BSC Group2.020.08Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.33
        value
        1.9
      2. group Id
        OG001
        spread
        17.95
        value
        0.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        261
      2. group Id
        OG001
        value
        126
      units
      Participants
    title
    Cycle 1 Day 1 - Pre-dose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.60
        value
        -0.1
      2. group Id
        OG001
        spread
        19.70
        value
        2.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        149
      2. group Id
        OG001
        value
        71
      units
      Participants
    title
    Cycle 1 Day 1 - 1 hour
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.58
        value
        1.9
      2. group Id
        OG001
        spread
        20.13
        value
        3.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        272
      2. group Id
        OG001
        value
        131
      units
      Participants
    title
    Cycle 1 Day 1 - 2 hours
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.77
        value
        2.6
      2. group Id
        OG001
        spread
        18.03
        value
        3.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        143
      2. group Id
        OG001
        value
        70
      units
      Participants
    title
    Cycle 1 Day 1 - 3 hours
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.48
        value
        1.2
      2. group Id
        OG001
        spread
        17.66
        value
        0.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        136
      2. group Id
        OG001
        value
        67
      units
      Participants
    title
    Cycle 1 Day 1 - 4 hours
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.94
        value
        3.2
      2. group Id
        OG001
        spread
        20.31
        value
        -2.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        184
      2. group Id
        OG001
        value
        95
      units
      Participants
    title
    Cycle 1 Day 21 - Pre-dose
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.56
        value
        4.0
      2. group Id
        OG001
        spread
        16.77
        value
        -0.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        109
      2. group Id
        OG001
        value
        62
      units
      Participants
    title
    Cycle 1 Day 21 - 1 hour
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.06
        value
        5.0
      2. group Id
        OG001
        spread
        18.23
        value
        2.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        222
      2. group Id
        OG001
        value
        121
      units
      Participants
    title
    Cycle 1 Day 21 - 2 hours
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.46
        value
        5.9
      2. group Id
        OG001
        spread
        14.70
        value
        0.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        111
      2. group Id
        OG001
        value
        61
      units
      Participants
    title
    Cycle 1 Day 21 - 3 hours
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.98
        value
        3.9
      2. group Id
        OG001
        spread
        18.13
        value
        -0.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        103
      2. group Id
        OG001
        value
        58
      units
      Participants
    title
    Cycle 1 Day 21 - 4 hours
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.41
        value
        1.4
      2. group Id
        OG001
        spread
        24.28
        value
        4.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        229
      2. group Id
        OG001
        value
        86
      units
      Participants
    title
    Cycle 2 Day 21 - 2 hours
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        31.61
        value
        2.6
      2. group Id
        OG001
        spread
        20.08
        value
        2.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        141
      2. group Id
        OG001
        value
        28
      units
      Participants
    title
    Cycle 3 Day 21 - 2 hours
denoms
  1. counts
    1. group Id
      OG000
      value
      272
    2. group Id
      OG001
      value
      131
    units
    Participants
description
QT Interval: Ventricular depolarization plus ventricular repolarization Normal Range: 400 to 460 milliseconds (msec). QTc: QT interval corrected based on the patient's heart rate. QTcF: An electrocardiographic finding in which the QT interval corrected for heart rate using Fridericia's formula. QTc = QT/∛(RR) RR = Respiration rate.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received 5 mg of fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).
    id
    OG000
    title
    Fruquintinib + BSC Group
  2. description
    Participants received placebo matched to fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).
    id
    OG001
    title
    Placebo + BSC Group
param Type
MEAN
population Description
SP included all randomized participants who received at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at the specified time points.
reporting Status
POSTED
time Frame
Baseline, Cycle 1 (Day 1 and 21): Pre-dose, 1, 2, 3 and 4 hours; Cycle 2 and 3 (Day 21): Pre-dose (Each cycle = 28 days)
title
Change From Baseline of Electrocardiogram (ECG) Results - QTcF Intervals Using Fridericia's Formula
type
SECONDARY
unit Of Measure
millisecond (msec)

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

Preserved source evidence · Independent clinical review pending · Not medical advice