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NCT00069121 · OUTCOME

Number of Participants With at Least One Adverse Event by Most Severe Intensity

A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer · Source last updated 2020-03-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From time of very first drug intake to 28 days after very last drug intake (median [full range] duration of study treatment per arm: 5-FU/LV MAYO CLINIC: 145 [4-208] days; 5-FU/LV ROSWELL PARK: 204 [1-239] days; XELOX: 163 [1-275] days).

What was measured

The intensity of all adverse events (AEs) was categorized according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) (version 3.0) grading system. If an AE had occurred which was not contained in the NCI-CTC, a four-point scale (mild, moderate, severe, life-threatening) was used. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Only the most severe intensity was counted for multiple occurrences of an AE in one individual. See the AEs results table for details.

Analysis population: Safety Population: all participants who were randomized and did receive at least one dose of capecitabine, 5-FU, or oxaliplatin. Participants in the safety population were analyzed according to the study treatment they received.

Groups in this outcome

5-FU/LV MAYO CLINIC

Mayo Clinic regimen group: LV 20 mg/m\^2 IV bolus injection + 5-FU 425 mg/m\^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks)

5-FU/LV ROSWELL PARK

Roswell Park regimen group: LV 500 mg/m\^2 by two-hour IV infusion + 5-FU 500 mg/m\^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)

XELOX

Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m\^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight 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
5-FU/LV MAYO CLINIC657
5-FU/LV ROSWELL PARK269
XELOX938

Reported measurements

Mild AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
5-FU/LV MAYO CLINIC557Not reportedNot reportedNot reportedNot reported
5-FU/LV ROSWELL PARK256Not reportedNot reportedNot reportedNot reported
XELOX855Not reportedNot reportedNot reportedNot reported
Moderate AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
5-FU/LV MAYO CLINIC493Not reportedNot reportedNot reportedNot reported
5-FU/LV ROSWELL PARK217Not reportedNot reportedNot reportedNot reported
XELOX792Not reportedNot reportedNot reportedNot reported
Severe AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
5-FU/LV MAYO CLINIC299Not reportedNot reportedNot reportedNot reported
5-FU/LV ROSWELL PARK146Not reportedNot reportedNot reportedNot reported
XELOX548Not reportedNot reportedNot reportedNot reported
Life-Threatening
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
5-FU/LV MAYO CLINIC83Not reportedNot reportedNot reportedNot reported
5-FU/LV ROSWELL PARK21Not reportedNot reportedNot reportedNot reported
XELOX63Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        557
      2. group Id
        OG001
        value
        256
      3. group Id
        OG002
        value
        855
    title
    Mild AEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        493
      2. group Id
        OG001
        value
        217
      3. group Id
        OG002
        value
        792
    title
    Moderate AEs
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        299
      2. group Id
        OG001
        value
        146
      3. group Id
        OG002
        value
        548
    title
    Severe AEs
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        83
      2. group Id
        OG001
        value
        21
      3. group Id
        OG002
        value
        63
    title
    Life-Threatening
denoms
  1. counts
    1. group Id
      OG000
      value
      657
    2. group Id
      OG001
      value
      269
    3. group Id
      OG002
      value
      938
    units
    Participants
description
The intensity of all adverse events (AEs) was categorized according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) (version 3.0) grading system. If an AE had occurred which was not contained in the NCI-CTC, a four-point scale (mild, moderate, severe, life-threatening) was used. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Only the most severe intensity was counted for multiple occurrences of an AE in one individual. See the AEs results table for details.
groups
  1. description
    Mayo Clinic regimen group: LV 20 mg/m\^2 IV bolus injection + 5-FU 425 mg/m\^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks)
    id
    OG000
    title
    5-FU/LV MAYO CLINIC
  2. description
    Roswell Park regimen group: LV 500 mg/m\^2 by two-hour IV infusion + 5-FU 500 mg/m\^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)
    id
    OG001
    title
    5-FU/LV ROSWELL PARK
  3. description
    Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m\^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
    id
    OG002
    title
    XELOX
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety Population: all participants who were randomized and did receive at least one dose of capecitabine, 5-FU, or oxaliplatin. Participants in the safety population were analyzed according to the study treatment they received.
reporting Status
POSTED
time Frame
From time of very first drug intake to 28 days after very last drug intake (median [full range] duration of study treatment per arm: 5-FU/LV MAYO CLINIC: 145 [4-208] days; 5-FU/LV ROSWELL PARK: 204 [1-239] days; XELOX: 163 [1-275] days).
title
Number of Participants With at Least One Adverse Event by Most Severe Intensity
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice