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NCT01456039 · OUTCOME

The Percentage of Participants With Abnormal Q-wave and T Wave Intervals

A Japanese Phase 1/2 Study to Assess the Efficacy, Safety and Pharmacokinetics of Romidepsin in Patients With Peripheral T-cell Lymphoma (PTCL) · Source last updated 2019-02-11

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Median follow-up: 100 days; up to data cut-off of 28 July 2015

What was measured

The time from the start of the Q-wave to the end of the T-wave QTc intervals greater than 450 msec post-baseline performed by centralized reviewer. The Bazett's (QTcB) and Fridericia (QTcF) correction were used as the standard clinical correction for calculating the heart rate-corrected QTc interval

Analysis population: The ECG population includes all participants who received romidepsin on Day 1 of Cycle 1 with at least one post-baseline QTc result

Groups in this outcome

Phase 1: Romidepsin 9mg/m^2

Romidepsin 9mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle

Phase 1: Romidepsin 14mg/m^2

Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.

Phase 2: Romidepsin 14mg/m^2

Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.

Total: Romidepsin 14mg/m^2

Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.

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

Analysis denominator · Participants

GroupSource count
Phase 1: Romidepsin 9mg/m^23
Phase 1: Romidepsin 14mg/m^27
Phase 2: Romidepsin 14mg/m^240
Total: Romidepsin 14mg/m^247

Reported measurements

QTcB >450 msec
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Romidepsin 9mg/m^2100Not reportedNot reportedNot reportedNot reported
Phase 1: Romidepsin 14mg/m^257.1Not reportedNot reportedNot reportedNot reported
Phase 2: Romidepsin 14mg/m^255.0Not reportedNot reportedNot reportedNot reported
Total: Romidepsin 14mg/m^255.3Not reportedNot reportedNot reportedNot reported
QTcB >480 msec
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Romidepsin 9mg/m^266.7Not reportedNot reportedNot reportedNot reported
Phase 1: Romidepsin 14mg/m^228.6Not reportedNot reportedNot reportedNot reported
Phase 2: Romidepsin 14mg/m^20.0Not reportedNot reportedNot reportedNot reported
Total: Romidepsin 14mg/m^24.3Not reportedNot reportedNot reportedNot reported
QTcB >500 msec
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Romidepsin 9mg/m^233.3Not reportedNot reportedNot reportedNot reported
Phase 1: Romidepsin 14mg/m^214.3Not reportedNot reportedNot reportedNot reported
Phase 2: Romidepsin 14mg/m^20.0Not reportedNot reportedNot reportedNot reported
Total: Romidepsin 14mg/m^22.1Not reportedNot reportedNot reportedNot reported
QTcB increase from predose >30 msec
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Romidepsin 9mg/m^266.7Not reportedNot reportedNot reportedNot reported
Phase 1: Romidepsin 14mg/m^257.1Not reportedNot reportedNot reportedNot reported
Phase 2: Romidepsin 14mg/m^210.0Not reportedNot reportedNot reportedNot reported
Total: Romidepsin 14mg/m^217.0Not reportedNot reportedNot reportedNot reported
QTcB increase from predose >60 msec
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Romidepsin 9mg/m^233.3Not reportedNot reportedNot reportedNot reported
Phase 1: Romidepsin 14mg/m^228.6Not reportedNot reportedNot reportedNot reported
Phase 2: Romidepsin 14mg/m^20.0Not reportedNot reportedNot reportedNot reported
Total: Romidepsin 14mg/m^24.3Not reportedNot reportedNot reportedNot reported
QTcF >450 msec
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Romidepsin 9mg/m^233.3Not reportedNot reportedNot reportedNot reported
Phase 1: Romidepsin 14mg/m^214.3Not reportedNot reportedNot reportedNot reported
Phase 2: Romidepsin 14mg/m^210.0Not reportedNot reportedNot reportedNot reported
Total: Romidepsin 14mg/m^210.6Not reportedNot reportedNot reportedNot reported
QTcF >480 msec
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Romidepsin 9mg/m^233.3Not reportedNot reportedNot reportedNot reported
Phase 1: Romidepsin 14mg/m^214.3Not reportedNot reportedNot reportedNot reported
Phase 2: Romidepsin 14mg/m^20.0Not reportedNot reportedNot reportedNot reported
Total: Romidepsin 14mg/m^22.1Not reportedNot reportedNot reportedNot reported
QTcF >500 msec
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Romidepsin 9mg/m^233.3Not reportedNot reportedNot reportedNot reported
Phase 1: Romidepsin 14mg/m^214.3Not reportedNot reportedNot reportedNot reported
Phase 2: Romidepsin 14mg/m^20.0Not reportedNot reportedNot reportedNot reported
Total: Romidepsin 14mg/m^22.1Not reportedNot reportedNot reportedNot reported
QTcF increase from predose >30 msec
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Romidepsin 9mg/m^266.7Not reportedNot reportedNot reportedNot reported
Phase 1: Romidepsin 14mg/m^257.1Not reportedNot reportedNot reportedNot reported
Phase 2: Romidepsin 14mg/m^210.0Not reportedNot reportedNot reportedNot reported
Total: Romidepsin 14mg/m^217.0Not reportedNot reportedNot reportedNot reported
QTcF increase from predose >60 msec
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Romidepsin 9mg/m^233.3Not reportedNot reportedNot reportedNot reported
Phase 1: Romidepsin 14mg/m^214.3Not reportedNot reportedNot reportedNot reported
Phase 2: Romidepsin 14mg/m^20.0Not reportedNot reportedNot reportedNot reported
Total: Romidepsin 14mg/m^22.1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        100
      2. group Id
        OG001
        value
        57.1
      3. group Id
        OG002
        value
        55.0
      4. group Id
        OG003
        value
        55.3
    title
    QTcB >450 msec
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        66.7
      2. group Id
        OG001
        value
        28.6
      3. group Id
        OG002
        value
        0.0
      4. group Id
        OG003
        value
        4.3
    title
    QTcB >480 msec
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        33.3
      2. group Id
        OG001
        value
        14.3
      3. group Id
        OG002
        value
        0.0
      4. group Id
        OG003
        value
        2.1
    title
    QTcB >500 msec
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        66.7
      2. group Id
        OG001
        value
        57.1
      3. group Id
        OG002
        value
        10.0
      4. group Id
        OG003
        value
        17.0
    title
    QTcB increase from predose >30 msec
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        33.3
      2. group Id
        OG001
        value
        28.6
      3. group Id
        OG002
        value
        0.0
      4. group Id
        OG003
        value
        4.3
    title
    QTcB increase from predose >60 msec
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        33.3
      2. group Id
        OG001
        value
        14.3
      3. group Id
        OG002
        value
        10.0
      4. group Id
        OG003
        value
        10.6
    title
    QTcF >450 msec
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        33.3
      2. group Id
        OG001
        value
        14.3
      3. group Id
        OG002
        value
        0.0
      4. group Id
        OG003
        value
        2.1
    title
    QTcF >480 msec
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        33.3
      2. group Id
        OG001
        value
        14.3
      3. group Id
        OG002
        value
        0.0
      4. group Id
        OG003
        value
        2.1
    title
    QTcF >500 msec
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        66.7
      2. group Id
        OG001
        value
        57.1
      3. group Id
        OG002
        value
        10.0
      4. group Id
        OG003
        value
        17.0
    title
    QTcF increase from predose >30 msec
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        33.3
      2. group Id
        OG001
        value
        14.3
      3. group Id
        OG002
        value
        0.0
      4. group Id
        OG003
        value
        2.1
    title
    QTcF increase from predose >60 msec
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      40
    4. group Id
      OG003
      value
      47
    units
    Participants
description
The time from the start of the Q-wave to the end of the T-wave QTc intervals greater than 450 msec post-baseline performed by centralized reviewer. The Bazett's (QTcB) and Fridericia (QTcF) correction were used as the standard clinical correction for calculating the heart rate-corrected QTc interval
groups
  1. description
    Romidepsin 9mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
    id
    OG000
    title
    Phase 1: Romidepsin 9mg/m^2
  2. description
    Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
    id
    OG001
    title
    Phase 1: Romidepsin 14mg/m^2
  3. description
    Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
    id
    OG002
    title
    Phase 2: Romidepsin 14mg/m^2
  4. description
    Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
    id
    OG003
    title
    Total: Romidepsin 14mg/m^2
param Type
NUMBER
population Description
The ECG population includes all participants who received romidepsin on Day 1 of Cycle 1 with at least one post-baseline QTc result
reporting Status
POSTED
time Frame
Median follow-up: 100 days; up to data cut-off of 28 July 2015
title
The Percentage of Participants With Abnormal Q-wave and T Wave Intervals
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice