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NCT00753688 · OUTCOME

Number of Participants With the Indicated Grade Shifts From Baseline Grade for Hemoglobin Level, Lymphocyte Count, White Blood Cell Count, Neutrophil Count, and Platelet Count

Pazopanib Versus Placebo in Patients With Soft Tissue Sarcoma Whose Disease Has Progressed During or Following Prior Therapy · Source last updated 2013-08-22

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
From baseline (Day 1) until study drug discontinuation or end of treatment (assessed for an average of 20 weeks)

What was measured

Shifts in hematology values by grade were summarized based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE Version 3.0). Grade refers to the severity of the AE. The CTCAE Version 3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline. Participants with a missing baseline grade were assumed to have a baseline Grade of 0. Any increase in grade from baseline and shifts to Grade 3 (severe AE) and 4 (life-threatening or disabling AE) at any point in the study after baseline are reported.

Analysis population: Safety Population. Data were analyzed for participants who were on-therapy and provided data at the indicated time point.

Groups in this outcome

Placebo

Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent

Pazopanib

Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent

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

Analysis denominator · Participants

GroupSource count
Placebo123
Pazopanib239

Reported measurements

Hemoglobin, Any Increase, n=123, 239
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo28Not reportedNot reportedNot reportedNot reported
Pazopanib65Not reportedNot reportedNot reportedNot reported
Hemoglobin, Increase to Grade 3, n=123, 239
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo1Not reportedNot reportedNot reportedNot reported
Pazopanib11Not reportedNot reportedNot reportedNot reported
Hemoglobin, Increase to Grade 4, n=123, 239
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo1Not reportedNot reportedNot reportedNot reported
Pazopanib4Not reportedNot reportedNot reportedNot reported
Lymphocytes, Any Increase, n=123, 238
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo44Not reportedNot reportedNot reportedNot reported
Pazopanib102Not reportedNot reportedNot reportedNot reported
Lymphocytes, Increase to Grade 3, n=123, 238
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo11Not reportedNot reportedNot reportedNot reported
Pazopanib23Not reportedNot reportedNot reportedNot reported
Lymphocytes, Increase to Grade 4, n=123, 238
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo2Not reportedNot reportedNot reportedNot reported
Pazopanib0Not reportedNot reportedNot reportedNot reported
Neutrophils, Any Increase, n=123, 239
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo8Not reportedNot reportedNot reportedNot reported
Pazopanib79Not reportedNot reportedNot reportedNot reported
Neutrophils, Increase to Grade 3, n=123, 239
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo0Not reportedNot reportedNot reportedNot reported
Pazopanib10Not reportedNot reportedNot reportedNot reported
Neutrophils, Increase to Grade 4, n=123, 239
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo0Not reportedNot reportedNot reportedNot reported
Pazopanib0Not reportedNot reportedNot reportedNot reported
Platelets, Any Increase, n=123, 239
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo7Not reportedNot reportedNot reportedNot reported
Pazopanib86Not reportedNot reportedNot reportedNot reported
Platelets, Increase to Grade 3, n=123, 239
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo0Not reportedNot reportedNot reportedNot reported
Pazopanib7Not reportedNot reportedNot reportedNot reported
Platelets, Increase to Grade 4, n=123, 239
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo0Not reportedNot reportedNot reportedNot reported
Pazopanib2Not reportedNot reportedNot reportedNot reported
White Blood Cells, Any Increase, n=123, 239
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo18Not reportedNot reportedNot reportedNot reported
Pazopanib106Not reportedNot reportedNot reportedNot reported
White Blood Cells, Increase to Grade 3, n=123, 239
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo0Not reportedNot reportedNot reportedNot reported
Pazopanib3Not reportedNot reportedNot reportedNot reported
White Blood Cells, Increase to Grade , n=123, 239
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo0Not reportedNot reportedNot reportedNot reported
Pazopanib0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        65
    title
    Hemoglobin, Any Increase, n=123, 239
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        11
    title
    Hemoglobin, Increase to Grade 3, n=123, 239
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        4
    title
    Hemoglobin, Increase to Grade 4, n=123, 239
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        44
      2. group Id
        OG001
        value
        102
    title
    Lymphocytes, Any Increase, n=123, 238
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        23
    title
    Lymphocytes, Increase to Grade 3, n=123, 238
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
    title
    Lymphocytes, Increase to Grade 4, n=123, 238
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        79
    title
    Neutrophils, Any Increase, n=123, 239
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        10
    title
    Neutrophils, Increase to Grade 3, n=123, 239
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Neutrophils, Increase to Grade 4, n=123, 239
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        86
    title
    Platelets, Any Increase, n=123, 239
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        7
    title
    Platelets, Increase to Grade 3, n=123, 239
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    Platelets, Increase to Grade 4, n=123, 239
denoms
  1. counts
    1. group Id
      OG000
      value
      123
    2. group Id
      OG001
      value
      239
    units
    Participants
description
Shifts in hematology values by grade were summarized based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE Version 3.0). Grade refers to the severity of the AE. The CTCAE Version 3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline. Participants with a missing baseline grade were assumed to have a baseline Grade of 0. Any increase in grade from baseline and shifts to Grade 3 (severe AE) and 4 (life-threatening or disabling AE) at any point in the study after baseline are reported.
groups
  1. description
    Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
    id
    OG000
    title
    Placebo
  2. description
    Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
    id
    OG001
    title
    Pazopanib
param Type
NUMBER
population Description
Safety Population. Data were analyzed for participants who were on-therapy and provided data at the indicated time point.
reporting Status
POSTED
time Frame
From baseline (Day 1) until study drug discontinuation or end of treatment (assessed for an average of 20 weeks)
title
Number of Participants With the Indicated Grade Shifts From Baseline Grade for Hemoglobin Level, Lymphocyte Count, White Blood Cell Count, Neutrophil Count, and Platelet Count
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice