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NCT01844765 · OUTCOME

Acceptability (Including Palatability) of Dose Forms Used After First Dose, Cycle 1 and Cycle 12 Study Drug Formulation

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
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
up to Cycle 12

What was measured

Acceptability of the study drug was evaluated from a questionnaire completed by patients, with the help from parents or caregivers at visits. The Questionnaire to capture patient assessment of palatability (very good to very bad) and acceptability of taking the medication (very easy to very hard to administration).

Analysis population: Safety Set (SAF): All patients who received at least one dose of study medication.

Groups in this outcome

All Patients

All patients enrolled in the study

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 Patients58

Reported measurements

Cycle (C) 1 Day (D) 1: Completed questionnaire - Patients
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients75.9Not reportedNot reportedNot reportedNot reported
C1D1: Completed questionnaire - Parents/Caregivers
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients22.4Not reportedNot reportedNot reportedNot reported
C1D1: Patients who swallowed capsule whole
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients91.4Not reportedNot reportedNot reportedNot reported
C1D1: Patients had capsule mixed with apple sauce
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients6.9Not reportedNot reportedNot reportedNot reported
C1D1: Patients who reported no taste/unable to answer question
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients43.1Not reportedNot reportedNot reportedNot reported
C1D1: Patients who reported taste as good/very good
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients12.1Not reportedNot reportedNot reportedNot reported
C1D1: Patients who reported taste as not good/not bad
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients34.5Not reportedNot reportedNot reportedNot reported
C1D1: Reported capsule to be very easy/easy to administer
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients79.3Not reportedNot reportedNot reportedNot reported
C1D28: Completed questionnaire - Patients
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients55.2Not reportedNot reportedNot reportedNot reported
C1D28: Completed questionnaire - Parents/Caregivers
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients22.4Not reportedNot reportedNot reportedNot reported
C12D28: Completed questionnaire - Patients
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients55.2Not reportedNot reportedNot reportedNot reported
C12D28: Completed questionnaire - Parents/Caregivers
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients22.4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        75.9
    title
    Cycle (C) 1 Day (D) 1: Completed questionnaire - Patients
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        22.4
    title
    C1D1: Completed questionnaire - Parents/Caregivers
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        91.4
    title
    C1D1: Patients who swallowed capsule whole
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        6.9
    title
    C1D1: Patients had capsule mixed with apple sauce
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        43.1
    title
    C1D1: Patients who reported no taste/unable to answer question
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        12.1
    title
    C1D1: Patients who reported taste as good/very good
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        34.5
    title
    C1D1: Patients who reported taste as not good/not bad
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        79.3
    title
    C1D1: Reported capsule to be very easy/easy to administer
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        55.2
    title
    C1D28: Completed questionnaire - Patients
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        22.4
    title
    C1D28: Completed questionnaire - Parents/Caregivers
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        55.2
    title
    C12D28: Completed questionnaire - Patients
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        22.4
    title
    C12D28: Completed questionnaire - Parents/Caregivers
denoms
  1. counts
    1. group Id
      OG000
      value
      58
    units
    Participants
description
Acceptability of the study drug was evaluated from a questionnaire completed by patients, with the help from parents or caregivers at visits. The Questionnaire to capture patient assessment of palatability (very good to very bad) and acceptability of taking the medication (very easy to very hard to administration).
groups
  1. description
    All patients enrolled in the study
    id
    OG000
    title
    All Patients
param Type
NUMBER
population Description
Safety Set (SAF): All patients who received at least one dose of study medication.
reporting Status
POSTED
time Frame
up to Cycle 12
title
Acceptability (Including Palatability) of Dose Forms Used After First Dose, Cycle 1 and Cycle 12 Study Drug Formulation
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice