Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01064310 · OUTCOME

Change From Baseline (BL) in Heart Rate

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
MEAN
Unit
Beats per minute
Interval / dispersion
Standard Deviation
Time frame
Baseline of Period (P) 1 (Screening); Period 1 Weeks 2 and 6 (Study Weeks 2 and 6); Baseline of Period 2 (Washout=Study Week 12); Period 2 Weeks 2, 6, and 10 (Study Weeks 14, 18, and 22)

What was measured

Heart rate (HR) is the number of heartbeats per unit of time, typically expressed as beats per minute. HR can vary as the body's need to absorb oxygen and excrete carbon dioxide changes, such as during exercise or sleep. A normal resting HR ranges from 60 to 100 beats per minute. Mean change from BL for each assessment week was calculated as the average change from period BL at the specified visits (combining data across P 1 and 2 for Weeks 2 and 6). Study weeks are approximate; participants could have crossed over from P 1 to P 2 at earlier time points than specified in the protocol.

Analysis population: Safety-Randomized Study Population. All participants who received sunitinib or pazopanib either during Period 1 or Period 2 were counted in both treatment groups (sunitinib and pazopanib). Only those participants contributing data at the indicated time points 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
Sunitinib137
Pazopanib145

Reported measurements

Week 2, n=137, 145
Values in Beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sunitinib-3.112.39Not reportedNot reportedNot reported
Pazopanib-2.713.09Not reportedNot reportedNot reported
Week 6, n=106, 131
Values in Beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sunitinib0.811.43Not reportedNot reportedNot reported
Pazopanib-3.312.41Not reportedNot reportedNot reported
Week 10, n=60, 64
Values in Beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sunitinib-3.813.54Not reportedNot reportedNot reported
Pazopanib-1.813.84Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.39
        value
        -3.1
      2. group Id
        OG001
        spread
        13.09
        value
        -2.7
    title
    Week 2, n=137, 145
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.43
        value
        0.8
      2. group Id
        OG001
        spread
        12.41
        value
        -3.3
    title
    Week 6, n=106, 131
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.54
        value
        -3.8
      2. group Id
        OG001
        spread
        13.84
        value
        -1.8
    title
    Week 10, n=60, 64
denoms
  1. counts
    1. group Id
      OG000
      value
      137
    2. group Id
      OG001
      value
      145
    units
    Participants
description
Heart rate (HR) is the number of heartbeats per unit of time, typically expressed as beats per minute. HR can vary as the body's need to absorb oxygen and excrete carbon dioxide changes, such as during exercise or sleep. A normal resting HR ranges from 60 to 100 beats per minute. Mean change from BL for each assessment week was calculated as the average change from period BL at the specified visits (combining data across P 1 and 2 for Weeks 2 and 6). Study weeks are approximate; participants could have crossed over from P 1 to P 2 at earlier time points than specified in the protocol.
dispersion Type
Standard Deviation
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
MEAN
population Description
Safety-Randomized Study Population. All participants who received sunitinib or pazopanib either during Period 1 or Period 2 were counted in both treatment groups (sunitinib and pazopanib). Only those participants contributing data at the indicated time points were evaluated.
reporting Status
POSTED
time Frame
Baseline of Period (P) 1 (Screening); Period 1 Weeks 2 and 6 (Study Weeks 2 and 6); Baseline of Period 2 (Washout=Study Week 12); Period 2 Weeks 2, 6, and 10 (Study Weeks 14, 18, and 22)
title
Change From Baseline (BL) in Heart Rate
type
SECONDARY
unit Of Measure
Beats per minute

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

Preserved source evidence · Not medical advice