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NCT00009737 · OUTCOME

Number of Participants With Abnormalities for Blood Chemistry and Hematological Parameters

A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer · Source last updated 2016-06-22

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
Up to Week 25

What was measured

Laboratory abnormalities were categorized according to the National Cancer Institute of Canada Common Toxicity Criteria (NCIC - CTC) grading system (May 1991 revised) as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (life- threatening). Participants with abnormalities in hemoglobin, granulocytes, lymphocytes, neutrophils, neutrophils/granulocytes, platelets, white blood cell, potassium, serum creatinine, sodium, total bilirubin, alanine transaminase, aspartate aminotransferase, alkaline phosphatase, calcium (hyper), and calcium (hypo) with Grades 1-4 were presented.

Analysis population: The safety population comprises all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment.

Groups in this outcome

Capecitabine

Participants received capecitabine 1250 (mg/m \^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).

5-Fluorouracil + Leucovorin

Participants received leucovorin 20 mg/m \^ 2 followed by 5-fluorouracil at 425 mg/m \^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).

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

Analysis denominator · Participants

GroupSource count
Capecitabine995
5-Fluorouracil + Leucovorin974

Reported measurements

Alanine transaminase
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Capecitabine327Not reportedNot reportedNot reportedNot reported
5-Fluorouracil + Leucovorin333Not reportedNot reportedNot reportedNot reported
Aspartate aminotransferase
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Capecitabine300Not reportedNot reportedNot reportedNot reported
5-Fluorouracil + Leucovorin288Not reportedNot reportedNot reportedNot reported
Alkaline Phosphatase
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Capecitabine334Not reportedNot reportedNot reportedNot reported
5-Fluorouracil + Leucovorin289Not reportedNot reportedNot reportedNot reported
Calcium (Hyper)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Capecitabine67Not reportedNot reportedNot reportedNot reported
5-Fluorouracil + Leucovorin68Not reportedNot reportedNot reportedNot reported
Calcium (Hypo)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Capecitabine150Not reportedNot reportedNot reportedNot reported
5-Fluorouracil + Leucovorin112Not reportedNot reportedNot reportedNot reported
Granulocytes
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Capecitabine20Not reportedNot reportedNot reportedNot reported
5-Fluorouracil + Leucovorin43Not reportedNot reportedNot reportedNot reported
Hemoglobin
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Capecitabine691Not reportedNot reportedNot reportedNot reported
5-Fluorouracil + Leucovorin650Not reportedNot reportedNot reportedNot reported
Lymphocytes
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Capecitabine778Not reportedNot reportedNot reportedNot reported
5-Fluorouracil + Leucovorin744Not reportedNot reportedNot reportedNot reported
Neutrophils
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Capecitabine308Not reportedNot reportedNot reportedNot reported
5-Fluorouracil + Leucovorin596Not reportedNot reportedNot reportedNot reported
Neutrophils/Granulocytes
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Capecitabine316Not reportedNot reportedNot reportedNot reported
5-Fluorouracil + Leucovorin612Not reportedNot reportedNot reportedNot reported
Platelets
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Capecitabine182Not reportedNot reportedNot reportedNot reported
5-Fluorouracil + Leucovorin160Not reportedNot reportedNot reportedNot reported
Potassium
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Capecitabine209Not reportedNot reportedNot reportedNot reported
5-Fluorouracil + Leucovorin156Not reportedNot reportedNot reportedNot reported
Serum Creatinine
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Capecitabine157Not reportedNot reportedNot reportedNot reported
5-Fluorouracil + Leucovorin138Not reportedNot reportedNot reportedNot reported
Sodium
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Capecitabine189Not reportedNot reportedNot reportedNot reported
5-Fluorouracil + Leucovorin184Not reportedNot reportedNot reportedNot reported
Total Bilirubin
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Capecitabine501Not reportedNot reportedNot reportedNot reported
5-Fluorouracil + Leucovorin185Not reportedNot reportedNot reportedNot reported
White blood cell
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Capecitabine220Not reportedNot reportedNot reportedNot reported
5-Fluorouracil + Leucovorin409Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        327
      2. group Id
        OG001
        value
        333
    title
    Alanine transaminase
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        300
      2. group Id
        OG001
        value
        288
    title
    Aspartate aminotransferase
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        334
      2. group Id
        OG001
        value
        289
    title
    Alkaline Phosphatase
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        67
      2. group Id
        OG001
        value
        68
    title
    Calcium (Hyper)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        150
      2. group Id
        OG001
        value
        112
    title
    Calcium (Hypo)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        43
    title
    Granulocytes
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        691
      2. group Id
        OG001
        value
        650
    title
    Hemoglobin
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        778
      2. group Id
        OG001
        value
        744
    title
    Lymphocytes
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        308
      2. group Id
        OG001
        value
        596
    title
    Neutrophils
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        316
      2. group Id
        OG001
        value
        612
    title
    Neutrophils/Granulocytes
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        182
      2. group Id
        OG001
        value
        160
    title
    Platelets
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        209
      2. group Id
        OG001
        value
        156
    title
    Potassium
denoms
  1. counts
    1. group Id
      OG000
      value
      995
    2. group Id
      OG001
      value
      974
    units
    Participants
description
Laboratory abnormalities were categorized according to the National Cancer Institute of Canada Common Toxicity Criteria (NCIC - CTC) grading system (May 1991 revised) as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (life- threatening). Participants with abnormalities in hemoglobin, granulocytes, lymphocytes, neutrophils, neutrophils/granulocytes, platelets, white blood cell, potassium, serum creatinine, sodium, total bilirubin, alanine transaminase, aspartate aminotransferase, alkaline phosphatase, calcium (hyper), and calcium (hypo) with Grades 1-4 were presented.
groups
  1. description
    Participants received capecitabine 1250 (mg/m \^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
    id
    OG000
    title
    Capecitabine
  2. description
    Participants received leucovorin 20 mg/m \^ 2 followed by 5-fluorouracil at 425 mg/m \^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
    id
    OG001
    title
    5-Fluorouracil + Leucovorin
param Type
NUMBER
population Description
The safety population comprises all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment.
reporting Status
POSTED
time Frame
Up to Week 25
title
Number of Participants With Abnormalities for Blood Chemistry and Hematological Parameters
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice