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NCT04154189 · OUTCOME

Number of Participants Categorized Based on Overall Palatability and Acceptability Questionnaire Responses for Suspension of Lenvatinib

A Study to Compare the Efficacy and Safety of Ifosfamide and Etoposide With or Without Lenvatinib in Children, Adolescents and Young Adults With Relapsed and Refractory Osteosarcoma · Source last updated 2024-07-22

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Cycle 1 Day 1 (Cycle length = 21 days)

What was measured

The palatability and acceptability of lenvatinib oral suspension formulation was assessed using the Palatability Questionnaire. In the questionnaire, participants were asked to answer palatability and acceptability of lenvatinib suspension considering the following elements: taste, appearance, smell, how does it feel in the mouth and overall acceptability in terms of 7 responses: Super good, really good, good, may be good or may be bad, bad, really bad, super bad. In this outcome measure, number of participants have been reported per their overall palatability and acceptability responses.

Analysis population: Palatability and acceptability analysis set included all participants who received oral suspension of lenvatinib in Treatment Arm A and who received an optional lenvatinib suspension in Treatment Arm B and who answered at least 1 question in the palatability questionnaire. As planned, combined data for Lenvatinib from Treatment Arm A and B was reported for this outcome measure. Here "overall number of participants analyzed, N" signifies participants who were evaluable for this outcome measure.

Groups in this outcome

All Participants: Lenvatinib 14 mg/m^2

Participants received lenvatinib 14 mg/m\^2 suspension, orally, once daily in continuous 21-day cycles until PD, development of unacceptable toxicity, participant request, withdrawal of consent, or discontinuation of study by the sponsor. Participants who were unable to swallow capsules received lenvatinib as an extemporaneous suspension prepared from the capsule.

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 Participants: Lenvatinib 14 mg/m^25

Reported measurements

Super Bad
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants: Lenvatinib 14 mg/m^20Not reportedNot reportedNot reportedNot reported
Really Bad
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants: Lenvatinib 14 mg/m^20Not reportedNot reportedNot reportedNot reported
Bad
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants: Lenvatinib 14 mg/m^20Not reportedNot reportedNot reportedNot reported
May be Good or May be Bad
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants: Lenvatinib 14 mg/m^22Not reportedNot reportedNot reportedNot reported
Good
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants: Lenvatinib 14 mg/m^22Not reportedNot reportedNot reportedNot reported
Really Good
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants: Lenvatinib 14 mg/m^20Not reportedNot reportedNot reportedNot reported
Super Good
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants: Lenvatinib 14 mg/m^21Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Super Bad
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Really Bad
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Bad
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    May be Good or May be Bad
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Good
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Really Good
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Super Good
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
The palatability and acceptability of lenvatinib oral suspension formulation was assessed using the Palatability Questionnaire. In the questionnaire, participants were asked to answer palatability and acceptability of lenvatinib suspension considering the following elements: taste, appearance, smell, how does it feel in the mouth and overall acceptability in terms of 7 responses: Super good, really good, good, may be good or may be bad, bad, really bad, super bad. In this outcome measure, number of participants have been reported per their overall palatability and acceptability responses.
groups
  1. description
    Participants received lenvatinib 14 mg/m\^2 suspension, orally, once daily in continuous 21-day cycles until PD, development of unacceptable toxicity, participant request, withdrawal of consent, or discontinuation of study by the sponsor. Participants who were unable to swallow capsules received lenvatinib as an extemporaneous suspension prepared from the capsule.
    id
    OG000
    title
    All Participants: Lenvatinib 14 mg/m^2
param Type
COUNT_OF_PARTICIPANTS
population Description
Palatability and acceptability analysis set included all participants who received oral suspension of lenvatinib in Treatment Arm A and who received an optional lenvatinib suspension in Treatment Arm B and who answered at least 1 question in the palatability questionnaire. As planned, combined data for Lenvatinib from Treatment Arm A and B was reported for this outcome measure. Here "overall number of participants analyzed, N" signifies participants who were evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Cycle 1 Day 1 (Cycle length = 21 days)
title
Number of Participants Categorized Based on Overall Palatability and Acceptability Questionnaire Responses for Suspension of Lenvatinib
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice