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NCT01064310 · OUTCOME

Number of Participants With the Indicated Reason for Receiving a Dose Reduction

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

Dose reduction of study drug was a stepwise reduction of the dose of the study drug: one less capsule was received at each step reduction. Participants were monitored for approximately 10 to 14 days at each dose level. 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. Participants may be counted multiple times for the same "reason" for a dose reduction if the participant had multiple reductions for the same reason.

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

Adverse Event
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib46Not reportedNot reportedNot reportedNot reported
Pazopanib33Not reportedNot reportedNot reportedNot reported
Other
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sunitinib3Not reportedNot reportedNot reportedNot reported
Pazopanib0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        46
      2. group Id
        OG001
        value
        33
    title
    Adverse Event
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
    title
    Other
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    2. group Id
      OG001
      value
      20
    units
    Participants
description
Dose reduction of study drug was a stepwise reduction of the dose of the study drug: one less capsule was received at each step reduction. Participants were monitored for approximately 10 to 14 days at each dose level. 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. Participants may be counted multiple times for the same "reason" for a dose reduction if the participant had multiple reductions for the same reason.
reporting Status
POSTED
time Frame
End of second treatment period (maximum of 22 weeks)
title
Number of Participants With the Indicated Reason for Receiving a Dose Reduction
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice