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NCT01064310 · OUTCOME

Number of Participants With the Indicated Number of Dose Reductions

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 second treatment period (maximum of 22 weeks)

What was measured

Participants are recorded under the treatment they were receiving at the time the dose reduction was reported.

Analysis population: Safety-Randomized Study Population. Only those participants who had an dose reduction were evaluated.

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
Sunitinib30
Pazopanib20

Reported measurements

1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib16Not reportedNot reportedNot reportedNot reported
Pazopanib8Not reportedNot reportedNot reportedNot reported
2
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib10Not reportedNot reportedNot reportedNot reported
Pazopanib11Not reportedNot reportedNot reportedNot reported
3 or more
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib4Not reportedNot reportedNot reportedNot reported
Pazopanib1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        8
    title
    1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        11
    title
    2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        1
    title
    3 or more
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    2. group Id
      OG001
      value
      20
    units
    Participants
description
Participants are recorded under the treatment they were receiving at the time the dose reduction was reported.
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
Safety-Randomized Study Population. Only those participants who had an dose reduction were evaluated.
reporting Status
POSTED
time Frame
End of second treatment period (maximum of 22 weeks)
title
Number of Participants With the Indicated Number of Dose Reductions
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice