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NCT01064310 · OUTCOME

Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire

Patient Preference Study of Pazopanib Versus Sunitinib in Advanced or Metastatic Kidney Cancer · Source last updated 2017-04-17

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
End of treatment of both study drugs (maximum of 22 weeks)

What was measured

The PPQ is used to measure participants' preference for pazopanib or sunitinib for renal cell carcinoma management and is used to determine a participant's preference for 1 of the 2 drugs given in the 2 double-blind treatment periods. Participants were asked to select 1 of the following: 1. prefer the drug taken as the first treatment; 2. prefer the drug taken as the second treatment; or 3, no preference. Those participants who indicated a preference were asked to select the factors that had an influence on their treatment preference, as well as the most important reason for their preference.

Analysis population: mITT Population. Responses to some categories of the PPQ may be missing for some participants.

Groups in this outcome

Sunitinib

Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.

Pazopanib

Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.

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

Analysis denominator · Participants

GroupSource count
Sunitinib25
Pazopanib80

Reported measurements

Fatigue had less impact on life, Yes
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib12Not reportedNot reportedNot reportedNot reported
Pazopanib47Not reportedNot reportedNot reportedNot reported
Fatigue had less impact on life, No
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib8Not reportedNot reportedNot reportedNot reported
Pazopanib26Not reportedNot reportedNot reportedNot reported
Fatigue had less impact on life, not applicable (N
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib5Not reportedNot reportedNot reportedNot reported
Pazopanib6Not reportedNot reportedNot reportedNot reported
Soreness in hands/feet had less impact, Yes
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib6Not reportedNot reportedNot reportedNot reported
Pazopanib30Not reportedNot reportedNot reportedNot reported
Soreness in hands/feet had less impact, No
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib7Not reportedNot reportedNot reportedNot reported
Pazopanib22Not reportedNot reportedNot reportedNot reported
Soreness in hands/feet had less impact, NA
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib12Not reportedNot reportedNot reportedNot reported
Pazopanib28Not reportedNot reportedNot reportedNot reported
Soreness in mouth/throat had less impact, Yes
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib6Not reportedNot reportedNot reportedNot reported
Pazopanib32Not reportedNot reportedNot reportedNot reported
Soreness in mouth/throat had less impact, No
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib8Not reportedNot reportedNot reportedNot reported
Pazopanib25Not reportedNot reportedNot reportedNot reported
Soreness in mouth/throat had less impact, NA
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib11Not reportedNot reportedNot reportedNot reported
Pazopanib23Not reportedNot reportedNot reportedNot reported
Loss of appetite had less impact, Yes
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib10Not reportedNot reportedNot reportedNot reported
Pazopanib28Not reportedNot reportedNot reportedNot reported
Loss of appetite had less impact, No
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib8Not reportedNot reportedNot reportedNot reported
Pazopanib28Not reportedNot reportedNot reportedNot reported
Loss of appetite had less impact, NA
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib7Not reportedNot reportedNot reportedNot reported
Pazopanib22Not reportedNot reportedNot reportedNot reported
Change in hair color had less impact, Yes
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib5Not reportedNot reportedNot reportedNot reported
Pazopanib9Not reportedNot reportedNot reportedNot reported
Change in hair color had less impact, No
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib11Not reportedNot reportedNot reportedNot reported
Pazopanib51Not reportedNot reportedNot reportedNot reported
Change in hair color had less impact, NA
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib9Not reportedNot reportedNot reportedNot reported
Pazopanib20Not reportedNot reportedNot reportedNot reported
Nausea/vomiting had less impact, Yes
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib11Not reportedNot reportedNot reportedNot reported
Pazopanib32Not reportedNot reportedNot reportedNot reported
Nausea/vomiting had less impact, No
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib7Not reportedNot reportedNot reportedNot reported
Pazopanib30Not reportedNot reportedNot reportedNot reported
Nausea/vomiting had less impact, NA
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib7Not reportedNot reportedNot reportedNot reported
Pazopanib17Not reportedNot reportedNot reportedNot reported
Diarrhea had less impact, Yes
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib16Not reportedNot reportedNot reportedNot reported
Pazopanib21Not reportedNot reportedNot reportedNot reported
Diarrhea had less impact, No
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib5Not reportedNot reportedNot reportedNot reported
Pazopanib44Not reportedNot reportedNot reportedNot reported
Diarrhea had less impact, NA
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib4Not reportedNot reportedNot reportedNot reported
Pazopanib15Not reportedNot reportedNot reportedNot reported
Pain in stomach area had less impact, Yes
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib9Not reportedNot reportedNot reportedNot reported
Pazopanib23Not reportedNot reportedNot reportedNot reported
Pain in stomach area had less impact, No
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib4Not reportedNot reportedNot reportedNot reported
Pazopanib30Not reportedNot reportedNot reportedNot reported
Pain in stomach area had less impact, NA
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib12Not reportedNot reportedNot reportedNot reported
Pazopanib27Not reportedNot reportedNot reportedNot reported
Changes in food tastes had less impact, Yes
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib5Not reportedNot reportedNot reportedNot reported
Pazopanib44Not reportedNot reportedNot reportedNot reported
Changes in food tastes had less impact, No
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib14Not reportedNot reportedNot reportedNot reported
Pazopanib23Not reportedNot reportedNot reportedNot reported
Changes in food tastes had less impact, NA
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib6Not reportedNot reportedNot reportedNot reported
Pazopanib12Not reportedNot reportedNot reportedNot reported
Quality of life better, Yes
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib15Not reportedNot reportedNot reportedNot reported
Pazopanib65Not reportedNot reportedNot reportedNot reported
Quality of life better, No
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib6Not reportedNot reportedNot reportedNot reported
Pazopanib12Not reportedNot reportedNot reportedNot reported
Quality of life better, NA
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib4Not reportedNot reportedNot reportedNot reported
Pazopanib2Not reportedNot reportedNot reportedNot reported
Other, Yes
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib5Not reportedNot reportedNot reportedNot reported
Pazopanib14Not reportedNot reportedNot reportedNot reported
Other, No
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib0Not reportedNot reportedNot reportedNot reported
Pazopanib0Not reportedNot reportedNot reportedNot reported
Other, NA
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib20Not reportedNot reportedNot reportedNot reported
Pazopanib66Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        47
    title
    Fatigue had less impact on life, Yes
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        26
    title
    Fatigue had less impact on life, No
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        6
    title
    Fatigue had less impact on life, not applicable (N
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        30
    title
    Soreness in hands/feet had less impact, Yes
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        22
    title
    Soreness in hands/feet had less impact, No
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        28
    title
    Soreness in hands/feet had less impact, NA
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        32
    title
    Soreness in mouth/throat had less impact, Yes
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        25
    title
    Soreness in mouth/throat had less impact, No
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        23
    title
    Soreness in mouth/throat had less impact, NA
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        28
    title
    Loss of appetite had less impact, Yes
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        28
    title
    Loss of appetite had less impact, No
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        22
    title
    Loss of appetite had less impact, NA
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    2. group Id
      OG001
      value
      80
    units
    Participants
description
The PPQ is used to measure participants' preference for pazopanib or sunitinib for renal cell carcinoma management and is used to determine a participant's preference for 1 of the 2 drugs given in the 2 double-blind treatment periods. Participants were asked to select 1 of the following: 1. prefer the drug taken as the first treatment; 2. prefer the drug taken as the second treatment; or 3, no preference. Those participants who indicated a preference were asked to select the factors that had an influence on their treatment preference, as well as the most important reason for their preference.
groups
  1. description
    Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
    id
    OG000
    title
    Sunitinib
  2. description
    Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
    id
    OG001
    title
    Pazopanib
param Type
NUMBER
population Description
mITT Population. Responses to some categories of the PPQ may be missing for some participants.
reporting Status
POSTED
time Frame
End of treatment of both study drugs (maximum of 22 weeks)
title
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
type
PRIMARY
unit Of Measure
participants

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Preserved source evidence · Not medical advice