Skip to content
TriangleGet started
← Full study record

NCT04322539 · OUTCOME

Change From Baseline of ECG Results -QTcB Intervals Using Bazzett'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
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 msec. QTc: QT interval corrected based on the patient's heart rate. QTcB: An electrocardiographic finding in which the QT interval corrected for heart rate using Bazzett's formula.

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 timepoints.

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 Group258
Placebo + BSC Group122

Reported measurements

Cycle 1 Day 1 - Pre-dose

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group249
Placebo + BSC Group118
Values in msec · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group2.939.49Not reportedNot reportedNot reported
Placebo + BSC Group0.320.55Not reportedNot reportedNot reported
Cycle 1 Day 1 - 1 hour

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group142
Placebo + BSC Group69
Values in msec · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group-3.123.95Not reportedNot reportedNot reported
Placebo + BSC Group1.920.11Not reportedNot reportedNot reported
Cycle 1 Day 1 - 2 hours

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group258
Placebo + BSC Group122
Values in msec · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group-2.023.95Not reportedNot reportedNot reported
Placebo + BSC Group1.920.11Not reportedNot reportedNot reported
Cycle 1 Day 1 - 3 hours

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group136
Placebo + BSC Group68
Values in msec · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group-0.924.47Not reportedNot reportedNot reported
Placebo + BSC Group3.919.75Not reportedNot reportedNot reported
Cycle 1 Day 1 - 4 hours

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group130
Placebo + BSC Group65
Values in msec · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group-1.924.47Not reportedNot reportedNot reported
Placebo + BSC Group2.420.11Not reportedNot reportedNot reported
Cycle 1 Day 21 - Pre-dose

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group177
Placebo + BSC Group91
Values in msec · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group3.949.99Not reportedNot reportedNot reported
Placebo + BSC Group5.050.43Not reportedNot reportedNot reported
Cycle 1 Day 21 - 1 hour

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group177
Placebo + BSC Group60
Values in msec · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group-1.325.60Not reportedNot reportedNot reported
Placebo + BSC Group0.920.48Not reportedNot reportedNot reported
Cycle 1 Day 21 - 2 hours

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group212
Placebo + BSC Group117
Values in msec · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group1.642.28Not reportedNot reportedNot reported
Placebo + BSC Group4.319.57Not reportedNot reportedNot reported
Cycle 1 Day 21 - 3 hours

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group107
Placebo + BSC Group59
Values in msec · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group1.225.41Not reportedNot reportedNot reported
Placebo + BSC Group2.918.29Not reportedNot reportedNot reported
Cycle 1 Day 21 - 4 hours

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group99
Placebo + BSC Group56
Values in msec · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group0.225.91Not reportedNot reportedNot reported
Placebo + BSC Group2.820.13Not reportedNot reportedNot reported
Cycle 2 Day 21 - 2 hours

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group213
Placebo + BSC Group83
Values in msec · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group1.740.61Not reportedNot reportedNot reported
Placebo + BSC Group5.924.96Not reportedNot reportedNot reported
Cycle 3 Day 21 - 2 hours

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group132
Placebo + BSC Group28
Values in msec · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group4.272.35Not reportedNot reportedNot reported
Placebo + BSC Group1.622.06Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        39.49
        value
        2.9
      2. group Id
        OG001
        spread
        20.55
        value
        0.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        249
      2. group Id
        OG001
        value
        118
      units
      Participants
    title
    Cycle 1 Day 1 - Pre-dose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.95
        value
        -3.1
      2. group Id
        OG001
        spread
        20.11
        value
        1.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        142
      2. group Id
        OG001
        value
        69
      units
      Participants
    title
    Cycle 1 Day 1 - 1 hour
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.95
        value
        -2.0
      2. group Id
        OG001
        spread
        20.11
        value
        1.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        258
      2. group Id
        OG001
        value
        122
      units
      Participants
    title
    Cycle 1 Day 1 - 2 hours
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.47
        value
        -0.9
      2. group Id
        OG001
        spread
        19.75
        value
        3.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        136
      2. group Id
        OG001
        value
        68
      units
      Participants
    title
    Cycle 1 Day 1 - 3 hours
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.47
        value
        -1.9
      2. group Id
        OG001
        spread
        20.11
        value
        2.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        130
      2. group Id
        OG001
        value
        65
      units
      Participants
    title
    Cycle 1 Day 1 - 4 hours
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        49.99
        value
        3.9
      2. group Id
        OG001
        spread
        50.43
        value
        5.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        177
      2. group Id
        OG001
        value
        91
      units
      Participants
    title
    Cycle 1 Day 21 - Pre-dose
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.60
        value
        -1.3
      2. group Id
        OG001
        spread
        20.48
        value
        0.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        177
      2. group Id
        OG001
        value
        60
      units
      Participants
    title
    Cycle 1 Day 21 - 1 hour
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        42.28
        value
        1.6
      2. group Id
        OG001
        spread
        19.57
        value
        4.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        212
      2. group Id
        OG001
        value
        117
      units
      Participants
    title
    Cycle 1 Day 21 - 2 hours
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.41
        value
        1.2
      2. group Id
        OG001
        spread
        18.29
        value
        2.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        107
      2. group Id
        OG001
        value
        59
      units
      Participants
    title
    Cycle 1 Day 21 - 3 hours
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.91
        value
        0.2
      2. group Id
        OG001
        spread
        20.13
        value
        2.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        99
      2. group Id
        OG001
        value
        56
      units
      Participants
    title
    Cycle 1 Day 21 - 4 hours
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        40.61
        value
        1.7
      2. group Id
        OG001
        spread
        24.96
        value
        5.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        213
      2. group Id
        OG001
        value
        83
      units
      Participants
    title
    Cycle 2 Day 21 - 2 hours
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        72.35
        value
        4.2
      2. group Id
        OG001
        spread
        22.06
        value
        1.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        132
      2. group Id
        OG001
        value
        28
      units
      Participants
    title
    Cycle 3 Day 21 - 2 hours
denoms
  1. counts
    1. group Id
      OG000
      value
      258
    2. group Id
      OG001
      value
      122
    units
    Participants
description
QT Interval: Ventricular depolarization plus ventricular repolarization Normal Range: 400 to 460 msec. QTc: QT interval corrected based on the patient's heart rate. QTcB: An electrocardiographic finding in which the QT interval corrected for heart rate using Bazzett's formula.
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 timepoints.
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 ECG Results -QTcB Intervals Using Bazzett's Formula
type
SECONDARY
unit Of Measure
msec

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

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