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NCT01740427 · OUTCOME

Corrected QT Interval (QTc) Time-Matched Change From Baseline on Cycle 1 Day 14

A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2) · Source last updated 2024-11-14

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

Measure
LEAST_SQUARES_MEAN
Unit
msec
Interval / dispersion
90% Confidence Interval
Time frame
Time-matched triplicate ECGs were collected at 0 (predose), 2, 4, 6 and 8 hours on Day 0 and on Cycle1 Day14

What was measured

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and sent to a central laboratory for blinded manual adjudication. The average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR), by Bazette's formula (QTcB = QT divided by square root of RR) and corrected QT interval according to study-specific criteria (QTcS). Time-matched change from baseline values were reported for QTc analysis population.

Analysis population: QTc analysis set is a subset of as treated (AT) population who were in Group 1; their QTc was used to study the effect of palbociclib on QT interval via serial triplicate ECGs with PK draws; and who had \>= 1 pair of time-matched Day 0 and palbociclib postdose (Cycle1 Day14) measurements.

Groups in this outcome

Palbociclib Plus Letrozole

Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.

Placebo Plus Letrozole

Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.

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

Analysis denominator · Participants

GroupSource count
Palbociclib Plus Letrozole76
Placebo Plus Letrozole47

Reported measurements

QTcS at 0 hour
Values in msec · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole0.80Not reported-1.673.26Not reported
Placebo Plus Letrozole2.95Not reported-0.196.10Not reported
QTcS at 2 hour
Values in msec · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole3.32Not reported0.795.85Not reported
Placebo Plus Letrozole1.65Not reported-1.484.78Not reported
QTcS at 4 hour
Values in msec · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole2.76Not reported0.235.30Not reported
Placebo Plus Letrozole1.74Not reported-1.394.87Not reported
QTcS at 6 hour
Values in msec · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole4.49Not reported1.967.02Not reported
Placebo Plus Letrozole0.72Not reported-2.413.85Not reported
QTcS at 8 hour
Values in msec · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole0.94Not reported-1.603.48Not reported
Placebo Plus Letrozole3.14Not reported0.016.27Not reported
QTcF at 0 hour
Values in msec · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole1.10Not reported-1.393.58Not reported
Placebo Plus Letrozole3.06Not reported-0.116.23Not reported
QTcF at 2 hour
Values in msec · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole3.68Not reported1.126.23Not reported
Placebo Plus Letrozole1.73Not reported-1.434.88Not reported
QTcF at 4 hour
Values in msec · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole2.86Not reported0.315.41Not reported
Placebo Plus Letrozole1.54Not reported-1.624.70Not reported
QTcF at 6 hour
Values in msec · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole4.57Not reported2.017.12Not reported
Placebo Plus Letrozole0.71Not reported-2.443.87Not reported
QTcF at 8 hour
Values in msec · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole1.21Not reported-1.363.77Not reported
Placebo Plus Letrozole2.84Not reported-0.316.00Not reported
QTcB at 0 hour
Values in msec · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole-0.11Not reported-2.832.61Not reported
Placebo Plus Letrozole2.78Not reported-0.696.25Not reported
QTcB at 2 hour
Values in msec · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole1.46Not reported-1.344.25Not reported
Placebo Plus Letrozole0.83Not reported-2.634.28Not reported
QTcB at 4 hour
Values in msec · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole2.58Not reported-0.225.38Not reported
Placebo Plus Letrozole2.47Not reported-0.985.92Not reported
QTcB at 6 hour
Values in msec · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole4.03Not reported1.246.83Not reported
Placebo Plus Letrozole0.53Not reported-2.923.99Not reported
QTcB at 8 hour
Values in msec · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole-0.17Not reported-2.982.64Not reported
Placebo Plus Letrozole4.14Not reported0.697.59Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -1.67
        upper Limit
        3.26
        value
        0.80
      2. group Id
        OG001
        lower Limit
        -0.19
        upper Limit
        6.10
        value
        2.95
    title
    QTcS at 0 hour
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.79
        upper Limit
        5.85
        value
        3.32
      2. group Id
        OG001
        lower Limit
        -1.48
        upper Limit
        4.78
        value
        1.65
    title
    QTcS at 2 hour
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.23
        upper Limit
        5.30
        value
        2.76
      2. group Id
        OG001
        lower Limit
        -1.39
        upper Limit
        4.87
        value
        1.74
    title
    QTcS at 4 hour
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.96
        upper Limit
        7.02
        value
        4.49
      2. group Id
        OG001
        lower Limit
        -2.41
        upper Limit
        3.85
        value
        0.72
    title
    QTcS at 6 hour
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -1.60
        upper Limit
        3.48
        value
        0.94
      2. group Id
        OG001
        lower Limit
        0.01
        upper Limit
        6.27
        value
        3.14
    title
    QTcS at 8 hour
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -1.39
        upper Limit
        3.58
        value
        1.10
      2. group Id
        OG001
        lower Limit
        -0.11
        upper Limit
        6.23
        value
        3.06
    title
    QTcF at 0 hour
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.12
        upper Limit
        6.23
        value
        3.68
      2. group Id
        OG001
        lower Limit
        -1.43
        upper Limit
        4.88
        value
        1.73
    title
    QTcF at 2 hour
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.31
        upper Limit
        5.41
        value
        2.86
      2. group Id
        OG001
        lower Limit
        -1.62
        upper Limit
        4.70
        value
        1.54
    title
    QTcF at 4 hour
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.01
        upper Limit
        7.12
        value
        4.57
      2. group Id
        OG001
        lower Limit
        -2.44
        upper Limit
        3.87
        value
        0.71
    title
    QTcF at 6 hour
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -1.36
        upper Limit
        3.77
        value
        1.21
      2. group Id
        OG001
        lower Limit
        -0.31
        upper Limit
        6.00
        value
        2.84
    title
    QTcF at 8 hour
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -2.83
        upper Limit
        2.61
        value
        -0.11
      2. group Id
        OG001
        lower Limit
        -0.69
        upper Limit
        6.25
        value
        2.78
    title
    QTcB at 0 hour
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -1.34
        upper Limit
        4.25
        value
        1.46
      2. group Id
        OG001
        lower Limit
        -2.63
        upper Limit
        4.28
        value
        0.83
    title
    QTcB at 2 hour
denoms
  1. counts
    1. group Id
      OG000
      value
      76
    2. group Id
      OG001
      value
      47
    units
    Participants
description
Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and sent to a central laboratory for blinded manual adjudication. The average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR), by Bazette's formula (QTcB = QT divided by square root of RR) and corrected QT interval according to study-specific criteria (QTcS). Time-matched change from baseline values were reported for QTc analysis population.
dispersion Type
90% Confidence Interval
groups
  1. description
    Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
    id
    OG000
    title
    Palbociclib Plus Letrozole
  2. description
    Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
    id
    OG001
    title
    Placebo Plus Letrozole
param Type
LEAST_SQUARES_MEAN
population Description
QTc analysis set is a subset of as treated (AT) population who were in Group 1; their QTc was used to study the effect of palbociclib on QT interval via serial triplicate ECGs with PK draws; and who had \>= 1 pair of time-matched Day 0 and palbociclib postdose (Cycle1 Day14) measurements.
reporting Status
POSTED
time Frame
Time-matched triplicate ECGs were collected at 0 (predose), 2, 4, 6 and 8 hours on Day 0 and on Cycle1 Day14
title
Corrected QT Interval (QTc) Time-Matched Change From Baseline on Cycle 1 Day 14
type
SECONDARY
unit Of Measure
msec

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Preserved source evidence · Not medical advice