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NCT00387764 · OUTCOME

Number of Participants With the Indicated Worst-case Grade Increase From Baseline for the Indicated Hematology Parameters at Any Time Post-Baseline

Extension Study to VEG105192 to Assess Pazopanib in Patients With Advanced/Metastatic Renal Cell Cancer · Source last updated 2014-01-14

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 to investigational product discontinuation (up to 6.230 years)

What was measured

Hematology parameters were summarized according to NIH CTCAE, version 4.0. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. Data are presented for only those parameters for which an increase from Baseline occurred. Hematology parameters included: hemoglobin (anemia), lymphocytes (lymphocytopenia), neutrophils (neutropenia), platelets (thrombocytopenia), white blood cells (WBC \[leukopenia\]), and prothrombin time international normalized ratio (PT \[INR\]). Participants with missing Baseline grades are assumed to have a Baseline grade of 0.

Analysis population: ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ATS Population.

Groups in this outcome

Pazopanib 800 mg

Participants received pazopanib 800 milligrams (mg) once daily.

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

Analysis denominator · Participants

GroupSource count
Pazopanib 800 mg80

Reported measurements

Hemoglobin, any grade increase, n=78
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg29Not reportedNot reportedNot reportedNot reported
Hemoglobin, increase to Grade 3, n=78
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg2Not reportedNot reportedNot reportedNot reported
Hemoglobin, increas to Grade 4, n=78
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0Not reportedNot reportedNot reportedNot reported
INR (PT), any grade increase, n=67
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg10Not reportedNot reportedNot reportedNot reported
INR (PT), increase to Grade 3, n=67
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg2Not reportedNot reportedNot reportedNot reported
INR (PT), increase to Grade 4, n=67
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0Not reportedNot reportedNot reportedNot reported
Lymphocytes, any grade increase, n=78
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg34Not reportedNot reportedNot reportedNot reported
Lymphocytes, increase to Grade 3, n=78
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg7Not reportedNot reportedNot reportedNot reported
Lymphocytes, increase to Grade 4, n=78
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg2Not reportedNot reportedNot reportedNot reported
Neutrophils, any grade increase, n=78
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg29Not reportedNot reportedNot reportedNot reported
Neutrophils, increase to Grade 3, n=78
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg1Not reportedNot reportedNot reportedNot reported
Neutrophils, increase to Grade 4, n=78
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg1Not reportedNot reportedNot reportedNot reported
Platelets, any grade increase, n=78
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg31Not reportedNot reportedNot reportedNot reported
Platelets, increase to Grade 3, n=78
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg1Not reportedNot reportedNot reportedNot reported
Platelets, increase to Grade 4, n=78
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0Not reportedNot reportedNot reportedNot reported
WBC, any grade increase, n=78
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg32Not reportedNot reportedNot reportedNot reported
WBC, increase to Grade 3, n=78
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg2Not reportedNot reportedNot reportedNot reported
WBC, increase to Grade 4, n=78
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        29
    title
    Hemoglobin, any grade increase, n=78
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Hemoglobin, increase to Grade 3, n=78
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Hemoglobin, increas to Grade 4, n=78
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    title
    INR (PT), any grade increase, n=67
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    INR (PT), increase to Grade 3, n=67
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    INR (PT), increase to Grade 4, n=67
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        34
    title
    Lymphocytes, any grade increase, n=78
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Lymphocytes, increase to Grade 3, n=78
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Lymphocytes, increase to Grade 4, n=78
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        29
    title
    Neutrophils, any grade increase, n=78
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Neutrophils, increase to Grade 3, n=78
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Neutrophils, increase to Grade 4, n=78
denoms
  1. counts
    1. group Id
      OG000
      value
      80
    units
    Participants
description
Hematology parameters were summarized according to NIH CTCAE, version 4.0. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. Data are presented for only those parameters for which an increase from Baseline occurred. Hematology parameters included: hemoglobin (anemia), lymphocytes (lymphocytopenia), neutrophils (neutropenia), platelets (thrombocytopenia), white blood cells (WBC \[leukopenia\]), and prothrombin time international normalized ratio (PT \[INR\]). Participants with missing Baseline grades are assumed to have a Baseline grade of 0.
groups
  1. description
    Participants received pazopanib 800 milligrams (mg) once daily.
    id
    OG000
    title
    Pazopanib 800 mg
param Type
NUMBER
population Description
ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ATS Population.
reporting Status
POSTED
time Frame
From Baseline to investigational product discontinuation (up to 6.230 years)
title
Number of Participants With the Indicated Worst-case Grade Increase From Baseline for the Indicated Hematology Parameters at Any Time Post-Baseline
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice