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NCT01740427 · OUTCOME

Observed Plasma Trough Concentration (Ctrough) at Steady-State

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
GEOMETRIC_MEAN
Unit
Nanogram per milliliter (ng/mL)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
0 hour (predose) on Day 14 of cycles 1 and 2

What was measured

Summary of plasma palbociclib within-participant mean steady-state trough concentrations.

Analysis population: Pharmacokinetic analysis set was a subset of AT participants, who were treated with Palbociclib and had at least one measured plasma concentration. Here "Number Analyzed" signifies number of participants evaluable for specified rows.

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.

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 Letrozole423

Reported measurements

Cycle 1 Day 14

Analysis denominator · Participants

GroupSource count
Palbociclib Plus Letrozole395
Values in Nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole70.159Not reportedNot reportedNot reported
Cycle 2 Day 14

Analysis denominator · Participants

GroupSource count
Palbociclib Plus Letrozole401
Values in Nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole64.282Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        59
        value
        70.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        395
      units
      Participants
    title
    Cycle 1 Day 14
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        82
        value
        64.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        401
      units
      Participants
    title
    Cycle 2 Day 14
denoms
  1. counts
    1. group Id
      OG000
      value
      423
    units
    Participants
description
Summary of plasma palbociclib within-participant mean steady-state trough concentrations.
dispersion Type
Geometric Coefficient of Variation
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
param Type
GEOMETRIC_MEAN
population Description
Pharmacokinetic analysis set was a subset of AT participants, who were treated with Palbociclib and had at least one measured plasma concentration. Here "Number Analyzed" signifies number of participants evaluable for specified rows.
reporting Status
POSTED
time Frame
0 hour (predose) on Day 14 of cycles 1 and 2
title
Observed Plasma Trough Concentration (Ctrough) at Steady-State
type
SECONDARY
unit Of Measure
Nanogram per milliliter (ng/mL)

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

Preserved source evidence · Not medical advice