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NCT00387764 · OUTCOME

Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry 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

Clinical chemistry parameters were summarized according to NCI 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. Clinical chemistry parameters included: alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin (TB), calcium (hypercalcemia and hypocalcemia), creatinine, glucose (hyperglycemia and hypoglycemia), potassium (hyperkalemia and hypokalemia), magnesium (hypermagnesemia and hypomagnesemia), sodium (hypernatremia and hyponatremia), and phosphate.

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

ALP, any grade increase, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg26Not reportedNot reportedNot reportedNot reported
ALP, increase to Grade 3, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg2Not reportedNot reportedNot reportedNot reported
ALP, increase to Grade 4, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0Not reportedNot reportedNot reportedNot reported
ALT, any grade increase, n=78
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg39Not reportedNot reportedNot reportedNot reported
ALT, increase to Grade 3, n=78
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg5Not reportedNot reportedNot reportedNot reported
ALT, increase to Grade 4, n=78
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg1Not reportedNot reportedNot reportedNot reported
AST, any grade increase, n=78
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg43Not reportedNot reportedNot reportedNot reported
AST, increase to Grade 3, n=78
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg5Not reportedNot reportedNot reportedNot reported
AST, increase to Grade 4, n=78
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg1Not reportedNot reportedNot reportedNot reported
Creatinine, any grade increase, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg26Not reportedNot reportedNot reportedNot reported
Creatinine, increase Grade 3, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0Not reportedNot reportedNot reportedNot reported
Creatinine, increase Grade 4, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0Not reportedNot reportedNot reportedNot reported
Hypercalcemia, any grade increase, n=71
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg14Not reportedNot reportedNot reportedNot reported
Hypercalcemia, increase to Grade 3, n=71
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg1Not reportedNot reportedNot reportedNot reported
Hypercalcemia, increase to Grade 4, n=71
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg1Not reportedNot reportedNot reportedNot reported
Hyperglycemia, any grade increase, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg46Not reportedNot reportedNot reportedNot reported
Hyperglycemia, increase to Grade 3, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg1Not reportedNot reportedNot reportedNot reported
Hyperglycemia, increase to Grade 4, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0Not reportedNot reportedNot reportedNot reported
Hyperkalemia, any grade increase, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg28Not reportedNot reportedNot reportedNot reported
Hyperkalemia, increase to Grade 3, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg4Not reportedNot reportedNot reportedNot reported
Hyperkalemia, increase to Grade 4, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg1Not reportedNot reportedNot reportedNot reported
Hypermagnesemia, any grade increase, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg15Not reportedNot reportedNot reportedNot reported
Hypermagnesemia, increase to Grade 3, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg1Not reportedNot reportedNot reportedNot reported
Hypermagnesemia, increase to Grade 4, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg1Not reportedNot reportedNot reportedNot reported
Hypernatremia, any grade increase, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg9Not reportedNot reportedNot reportedNot reported
Hypernatremia, increase to Grade 3, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0Not reportedNot reportedNot reportedNot reported
Hypernatremia, increae to Grade 4, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0Not reportedNot reportedNot reportedNot reported
Hypocalcemia, any grade increase, n=71
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg30Not reportedNot reportedNot reportedNot reported
Hypocalcemia, increase to Grade 3, n=71
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg1Not reportedNot reportedNot reportedNot reported
Hypocalcemia, increase to Grade 4, n=71
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0Not reportedNot reportedNot reportedNot reported
Hypoglycemia, any grade increase, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg12Not reportedNot reportedNot reportedNot reported
Hypoglycemia, increase to Grade 3, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0Not reportedNot reportedNot reportedNot reported
Hypoglycemia, increase to Grade 4, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg1Not reportedNot reportedNot reportedNot reported
Hypokalemia, any grade increase, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg15Not reportedNot reportedNot reportedNot reported
Hypokalemia, increase to Grade 3, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0Not reportedNot reportedNot reportedNot reported
Hypokalemia, increase to Grade 4, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0Not reportedNot reportedNot reportedNot reported
Hypomagnesemia, any grade increase, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg17Not reportedNot reportedNot reportedNot reported
Hypomagnesemia, increase to Grade 3, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0Not reportedNot reportedNot reportedNot reported
Hypomagnesemia, increase Grade 4, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0Not reportedNot reportedNot reportedNot reported
Hyponatremia, any grade increase, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg29Not reportedNot reportedNot reportedNot reported
Hyponatremia, increase to Grade 3, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg6Not reportedNot reportedNot reportedNot reported
Hyponatremia, increase to Grade 4, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0Not reportedNot reportedNot reportedNot reported
Phosphate, any grade increase, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg32Not reportedNot reportedNot reportedNot reported
Phosphate, increase to Grade 3, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg3Not reportedNot reportedNot reportedNot reported
Phosphate, increase to Grade 4, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0Not reportedNot reportedNot reportedNot reported
TB, any grade increase, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg40Not reportedNot reportedNot reportedNot reported
TB, increase to Grade 3, n=77
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg4Not reportedNot reportedNot reportedNot reported
TB, increase to Grade 4, n=77
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
        26
    title
    ALP, any grade increase, n=77
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    ALP, increase to Grade 3, n=77
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    ALP, increase to Grade 4, n=77
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        39
    title
    ALT, any grade increase, n=78
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    ALT, increase to Grade 3, n=78
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    ALT, increase to Grade 4, n=78
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        43
    title
    AST, any grade increase, n=78
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    AST, increase to Grade 3, n=78
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    AST, increase to Grade 4, n=78
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        26
    title
    Creatinine, any grade increase, n=77
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Creatinine, increase Grade 3, n=77
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Creatinine, increase Grade 4, n=77
denoms
  1. counts
    1. group Id
      OG000
      value
      80
    units
    Participants
description
Clinical chemistry parameters were summarized according to NCI 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. Clinical chemistry parameters included: alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin (TB), calcium (hypercalcemia and hypocalcemia), creatinine, glucose (hyperglycemia and hypoglycemia), potassium (hyperkalemia and hypokalemia), magnesium (hypermagnesemia and hypomagnesemia), sodium (hypernatremia and hyponatremia), and phosphate.
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 Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry 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