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NCT00639769 · OUTCOME

Number of Patients With Each Worst-grade Toxicity

Irinotecan and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer · Source last updated 2012-09-14

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
6 weeks after last chemotherapy

What was measured

Number of patients with worst-grade toxicity response of each grade (grade 1 to 5) following NCI Common Toxicity Criteria, with grade 1=mild adverse event; 2=moderate adverse event; 3=severe and undesirable adverse event; 4=life-threatening or disabling adverse event; 5=death

Groups in this outcome

Therapeutic Intervention

Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2

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

Analysis denominator · Participants

GroupSource count
Therapeutic Intervention40

Reported measurements

No. of patients with worst-grade toxicity of 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Therapeutic Intervention2Not reportedNot reportedNot reportedNot reported
No. of patients with worst-grade toxicity of 2
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Therapeutic Intervention12Not reportedNot reportedNot reportedNot reported
No. of patients with worst-grade toxicity of 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Therapeutic Intervention21Not reportedNot reportedNot reportedNot reported
No. of patients with worst-grade toxicity of 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Therapeutic Intervention10Not reportedNot reportedNot reportedNot reported
No. of patients with worst-grade toxicity of 5
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Therapeutic Intervention1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    No. of patients with worst-grade toxicity of 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        12
    title
    No. of patients with worst-grade toxicity of 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        21
    title
    No. of patients with worst-grade toxicity of 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    title
    No. of patients with worst-grade toxicity of 4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    No. of patients with worst-grade toxicity of 5
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    units
    Participants
description
Number of patients with worst-grade toxicity response of each grade (grade 1 to 5) following NCI Common Toxicity Criteria, with grade 1=mild adverse event; 2=moderate adverse event; 3=severe and undesirable adverse event; 4=life-threatening or disabling adverse event; 5=death
groups
  1. description
    Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
    id
    OG000
    title
    Therapeutic Intervention
param Type
NUMBER
reporting Status
POSTED
time Frame
6 weeks after last chemotherapy
title
Number of Patients With Each Worst-grade Toxicity
type
SECONDARY
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice