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NCT01740427 · OUTCOME

Percentage of Participants With Corrected QT Interval (QTc)

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
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
For safety monitoring triplicate ECGs were obtained at 0 hour (pre-dose) on Day 1 of Cycle 1, Day 14 of Cycles 1 and Cycle 2, then on Day 1 of Cycles 4, 7, and 10 (ECGs beyond Cycle 10 were performed as clinically indicated)

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). Percentage of participants with post-baseline maximum absolute values and maximum increase from baseline were summarized for the safety analysis population.

Analysis population: The AT population or safety analysis set included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.

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 Letrozole441
Placebo Plus Letrozole220

Reported measurements

Maximum QTcS <450 msec
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole80.5Not reportedNot reportedNot reportedNot reported
Placebo Plus Letrozole85.9Not reportedNot reportedNot reportedNot reported
Maximum QTcS 450-<480 msec
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole17.9Not reportedNot reportedNot reportedNot reported
Placebo Plus Letrozole11.8Not reportedNot reportedNot reportedNot reported
Maximum QTcS 480-<500 msec
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole1.1Not reportedNot reportedNot reportedNot reported
Placebo Plus Letrozole2.3Not reportedNot reportedNot reportedNot reported
Maximum QTcS >=500 msec
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole0.5Not reportedNot reportedNot reportedNot reported
Placebo Plus Letrozole0Not reportedNot reportedNot reportedNot reported
Maximum QTcF <450 msec
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole85.9Not reportedNot reportedNot reportedNot reported
Placebo Plus Letrozole89.5Not reportedNot reportedNot reportedNot reported
Maximum QTcF 450-<480 msec
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole12.2Not reportedNot reportedNot reportedNot reported
Placebo Plus Letrozole9.5Not reportedNot reportedNot reportedNot reported
Maximum QTcF 480-<500 msec
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole1.6Not reportedNot reportedNot reportedNot reported
Placebo Plus Letrozole0.9Not reportedNot reportedNot reportedNot reported
Maximum QTcF >=500 msec
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole0.2Not reportedNot reportedNot reportedNot reported
Placebo Plus Letrozole0Not reportedNot reportedNot reportedNot reported
Maximum QTcB <450 msec
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole64.9Not reportedNot reportedNot reportedNot reported
Placebo Plus Letrozole69.1Not reportedNot reportedNot reportedNot reported
Maximum QTcB 450-<480 msec
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole32.2Not reportedNot reportedNot reportedNot reported
Placebo Plus Letrozole27.3Not reportedNot reportedNot reportedNot reported
Maximum QTcB 480-<500 msec
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole2.3Not reportedNot reportedNot reportedNot reported
Placebo Plus Letrozole3.2Not reportedNot reportedNot reportedNot reported
Maximum QTcB >=500 msec
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole0.7Not reportedNot reportedNot reportedNot reported
Placebo Plus Letrozole0.5Not reportedNot reportedNot reportedNot reported
Maximum QTcS Change <30 msec
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole92.7Not reportedNot reportedNot reportedNot reported
Placebo Plus Letrozole94.5Not reportedNot reportedNot reportedNot reported
Maximum QTcS 30<=Change <60 msec
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole6.6Not reportedNot reportedNot reportedNot reported
Placebo Plus Letrozole5.5Not reportedNot reportedNot reportedNot reported
Maximum QTcS Change>=60 msec
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole0.7Not reportedNot reportedNot reportedNot reported
Placebo Plus Letrozole0Not reportedNot reportedNot reportedNot reported
Maximum QTcF Change <30 msec
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole91.6Not reportedNot reportedNot reportedNot reported
Placebo Plus Letrozole93.6Not reportedNot reportedNot reportedNot reported
Maximum QTcF 30<=Change <60 msec
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole7.9Not reportedNot reportedNot reportedNot reported
Placebo Plus Letrozole6.4Not reportedNot reportedNot reportedNot reported
Maximum QTcF Change>=60 msec
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole0.5Not reportedNot reportedNot reportedNot reported
Placebo Plus Letrozole0Not reportedNot reportedNot reportedNot reported
Maximum QTcB Change <30 msec
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole88.9Not reportedNot reportedNot reportedNot reported
Placebo Plus Letrozole91.4Not reportedNot reportedNot reportedNot reported
Maximum QTcB 30<=Change <60 msec
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole10.2Not reportedNot reportedNot reportedNot reported
Placebo Plus Letrozole8.2Not reportedNot reportedNot reportedNot reported
Maximum QTcB Change>=60 msec
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole0.9Not reportedNot reportedNot reportedNot reported
Placebo Plus Letrozole0.5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        80.5
      2. group Id
        OG001
        value
        85.9
    title
    Maximum QTcS <450 msec
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        17.9
      2. group Id
        OG001
        value
        11.8
    title
    Maximum QTcS 450-<480 msec
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1.1
      2. group Id
        OG001
        value
        2.3
    title
    Maximum QTcS 480-<500 msec
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0.5
      2. group Id
        OG001
        value
        0
    title
    Maximum QTcS >=500 msec
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        85.9
      2. group Id
        OG001
        value
        89.5
    title
    Maximum QTcF <450 msec
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        12.2
      2. group Id
        OG001
        value
        9.5
    title
    Maximum QTcF 450-<480 msec
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1.6
      2. group Id
        OG001
        value
        0.9
    title
    Maximum QTcF 480-<500 msec
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0.2
      2. group Id
        OG001
        value
        0
    title
    Maximum QTcF >=500 msec
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        64.9
      2. group Id
        OG001
        value
        69.1
    title
    Maximum QTcB <450 msec
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        32.2
      2. group Id
        OG001
        value
        27.3
    title
    Maximum QTcB 450-<480 msec
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        2.3
      2. group Id
        OG001
        value
        3.2
    title
    Maximum QTcB 480-<500 msec
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0.7
      2. group Id
        OG001
        value
        0.5
    title
    Maximum QTcB >=500 msec
denoms
  1. counts
    1. group Id
      OG000
      value
      441
    2. group Id
      OG001
      value
      220
    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). Percentage of participants with post-baseline maximum absolute values and maximum increase from baseline were summarized for the safety analysis population.
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
NUMBER
population Description
The AT population or safety analysis set included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.
reporting Status
POSTED
time Frame
For safety monitoring triplicate ECGs were obtained at 0 hour (pre-dose) on Day 1 of Cycle 1, Day 14 of Cycles 1 and Cycle 2, then on Day 1 of Cycles 4, 7, and 10 (ECGs beyond Cycle 10 were performed as clinically indicated)
title
Percentage of Participants With Corrected QT Interval (QTc)
type
SECONDARY
unit Of Measure
Percentage of participants

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