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NCT02255461 · OUTCOME

Association Between Leukopenia and Single Dose Palbociclib AUC

Palbociclib Isethionate in Treating Younger Patients With Recurrent, Progressive, or Refractory Central Nervous System Tumors · Source last updated 2021-03-02

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

Measure
MEAN
Unit
h*ng/mL
Interval / dispersion
Standard Deviation
Time frame
Up to approximately 4 weeks

What was measured

White blood cell count decreased adverse events observed in course 1 that were at least possibly attributable to palbociclib were included in analysis. Based on the highest toxicity grade reported, all participants, irrespective of their dose level or stratum, were combined and classified into three categories: 0 = no toxicity reported, 1 = grade 1 or 2, and 2 = grade 3 or 4. Association between white blood cell count decreased and single dose palbociclib AUC for all participants was examined.

Analysis population: It was pre-specified that data from all participants from different dose levels and strata were combined to calculate an association between leukopenia and single dose AUC for all participants. Of 35 patients enrolled, one patient in stratum II withdrew prior to protocol therapy and was excluded.

Groups in this outcome

All Patients

All 34 patients who had course 1 single dose palbociclib AUC data available were included in analysis. Patients were classified into no leukopenia (n = 8), grade 1 or 2 leukopenia (n = 17), and grade 3 or 4 leukopenia (n = 9).

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

Analysis denominator · Participants

GroupSource count
All Patients34

Reported measurements

No leukopenia

Analysis denominator · Participants

GroupSource count
All Patients8
Values in h*ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Patients1420.3955.1Not reportedNot reportedNot reported
Grade 1 or 2 leukopenia

Analysis denominator · Participants

GroupSource count
All Patients17
Values in h*ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Patients1879.6682.6Not reportedNot reportedNot reported
Grade 3 or 4 leukopenia

Analysis denominator · Participants

GroupSource count
All Patients9
Values in h*ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Patients2171.6712.9Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    1.01
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.20
    group Ids
    1. OG000
    non Inferiority Comment
    Ordinal logistic regression model was built for outcome leukopenia (0/1/2). Explanatory variable AUC was transformed by dividing by 100.
    non Inferiority Type
    OTHER
    param Type
    Odds Ratio (OR)
    param Value
    1.10
Complete source fields
analyses
  1. ci Lower Limit
    1.01
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.20
    group Ids
    1. OG000
    non Inferiority Comment
    Ordinal logistic regression model was built for outcome leukopenia (0/1/2). Explanatory variable AUC was transformed by dividing by 100.
    non Inferiority Type
    OTHER
    param Type
    Odds Ratio (OR)
    param Value
    1.10
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        955.1
        value
        1420.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    No leukopenia
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        682.6
        value
        1879.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      units
      Participants
    title
    Grade 1 or 2 leukopenia
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        712.9
        value
        2171.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    Grade 3 or 4 leukopenia
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    units
    Participants
description
White blood cell count decreased adverse events observed in course 1 that were at least possibly attributable to palbociclib were included in analysis. Based on the highest toxicity grade reported, all participants, irrespective of their dose level or stratum, were combined and classified into three categories: 0 = no toxicity reported, 1 = grade 1 or 2, and 2 = grade 3 or 4. Association between white blood cell count decreased and single dose palbociclib AUC for all participants was examined.
dispersion Type
Standard Deviation
groups
  1. description
    All 34 patients who had course 1 single dose palbociclib AUC data available were included in analysis. Patients were classified into no leukopenia (n = 8), grade 1 or 2 leukopenia (n = 17), and grade 3 or 4 leukopenia (n = 9).
    id
    OG000
    title
    All Patients
param Type
MEAN
population Description
It was pre-specified that data from all participants from different dose levels and strata were combined to calculate an association between leukopenia and single dose AUC for all participants. Of 35 patients enrolled, one patient in stratum II withdrew prior to protocol therapy and was excluded.
reporting Status
POSTED
time Frame
Up to approximately 4 weeks
title
Association Between Leukopenia and Single Dose Palbociclib AUC
type
SECONDARY
unit Of Measure
h*ng/mL

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

Preserved source evidence · Not medical advice