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NCT01844765 · OUTCOME

Pharmacokinetics: Steady State Concentration of Nilotinib in Newly Diagnosed CML-CP Patients

Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients. · Source last updated 2021-04-22

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

Measure
GEOMETRIC_MEAN
Unit
ng/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1 Day 8

What was measured

PK was analyzed only when all patients has completed 12 cycles of treatment or discontinued the study treatment early.

Analysis population: Pharmacokinetics Analysis Set (PAS): All patients with at least one evaluable PK blood sample.

Groups in this outcome

Newly Diagnosed and Untreated Ph+ CML in First CP

Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis.

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

Analysis denominator · Participants

GroupSource count
Newly Diagnosed and Untreated Ph+ CML in First CP25

Reported measurements

Source class 1
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Newly Diagnosed and Untreated Ph+ CML in First CP1274.3046.21Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        46.21
        value
        1274.30
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    units
    Participants
description
PK was analyzed only when all patients has completed 12 cycles of treatment or discontinued the study treatment early.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis.
    id
    OG000
    title
    Newly Diagnosed and Untreated Ph+ CML in First CP
param Type
GEOMETRIC_MEAN
population Description
Pharmacokinetics Analysis Set (PAS): All patients with at least one evaluable PK blood sample.
reporting Status
POSTED
time Frame
Cycle 1 Day 8
title
Pharmacokinetics: Steady State Concentration of Nilotinib in Newly Diagnosed CML-CP Patients
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice