Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00005044 · OUTCOME

Treatment-induced Morbidity (Highest Grade Toxicity Reported Per Patient)

Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer · Source last updated 2022-06-15

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)

What was measured

Acute drug therapy and radiation (\<= 90 days from start of RT) toxicity was graded using the Common Toxicity Criteria (CTC) v.2.0 criteria; late toxicity was graded using the Radiation Therapy Oncology Group (RTOG)/European Organisation for Research and Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring schema. Grade refers to the severity of the toxicity. The CTC v2.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild toxicity, Grade 2 Moderate toxicity, Grade 3 Severe toxicity, Grade 4 Life-threatening or disabling toxicity, Grade 5 Death related to toxicity. The highest grade acute and late toxicity was determined for each patient.

Analysis population: Eligible patients with adverse event data in corresponding time frame (during hormone therapy and \<=90 days from RT start; \> 90 days from RT start)

Groups in this outcome

TAS x 8 Weeks

Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).

TAS x 28 Weeks

TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).

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

Analysis denominator · Participants

GroupSource count
TAS x 8 Weeks747
TAS x 28 Weeks735

Reported measurements

Acute RT and Hormone Toxicity: Grade 1

Analysis denominator · Participants

GroupSource count
TAS x 8 Weeks747
TAS x 28 Weeks735
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TAS x 8 Weeks30.8Not reportedNot reportedNot reportedNot reported
TAS x 28 Weeks19.5Not reportedNot reportedNot reportedNot reported
Acute RT and Hormone Toxicity: Grade 2

Analysis denominator · Participants

GroupSource count
TAS x 8 Weeks747
TAS x 28 Weeks735
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TAS x 8 Weeks41.6Not reportedNot reportedNot reportedNot reported
TAS x 28 Weeks49.8Not reportedNot reportedNot reportedNot reported
Acute RT and Hormone Toxicity: Grade 3

Analysis denominator · Participants

GroupSource count
TAS x 8 Weeks747
TAS x 28 Weeks735
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TAS x 8 Weeks16.1Not reportedNot reportedNot reportedNot reported
TAS x 28 Weeks25.7Not reportedNot reportedNot reportedNot reported
Acute RT and Hormone Toxicity: Grade 4

Analysis denominator · Participants

GroupSource count
TAS x 8 Weeks747
TAS x 28 Weeks735
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TAS x 8 Weeks0Not reportedNot reportedNot reportedNot reported
TAS x 28 Weeks0.1Not reportedNot reportedNot reportedNot reported
Acute RT and Hormone Toxicity: Grade 5

Analysis denominator · Participants

GroupSource count
TAS x 8 Weeks747
TAS x 28 Weeks735
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TAS x 8 Weeks0Not reportedNot reportedNot reportedNot reported
TAS x 28 Weeks0Not reportedNot reportedNot reportedNot reported
Late RT Toxicity: Grade 1

Analysis denominator · Participants

GroupSource count
TAS x 8 Weeks742
TAS x 28 Weeks724
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TAS x 8 Weeks34.0Not reportedNot reportedNot reportedNot reported
TAS x 28 Weeks32.9Not reportedNot reportedNot reportedNot reported
Late RT Toxicity: Grade 2

Analysis denominator · Participants

GroupSource count
TAS x 8 Weeks742
TAS x 28 Weeks724
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TAS x 8 Weeks20.5Not reportedNot reportedNot reportedNot reported
TAS x 28 Weeks22.5Not reportedNot reportedNot reportedNot reported
Late RT Toxicity: Grade 3

Analysis denominator · Participants

GroupSource count
TAS x 8 Weeks742
TAS x 28 Weeks724
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TAS x 8 Weeks9.7Not reportedNot reportedNot reportedNot reported
TAS x 28 Weeks8.0Not reportedNot reportedNot reportedNot reported
Late RT Toxicity: Grade 4

Analysis denominator · Participants

GroupSource count
TAS x 8 Weeks742
TAS x 28 Weeks724
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TAS x 8 Weeks0.1Not reportedNot reportedNot reportedNot reported
TAS x 28 Weeks0.3Not reportedNot reportedNot reportedNot reported
Late RT Toxicity: Grade 5

Analysis denominator · Participants

GroupSource count
TAS x 8 Weeks742
TAS x 28 Weeks724
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TAS x 8 Weeks0Not reportedNot reportedNot reportedNot reported
TAS x 28 Weeks0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        30.8
      2. group Id
        OG001
        value
        19.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        747
      2. group Id
        OG001
        value
        735
      units
      Participants
    title
    Acute RT and Hormone Toxicity: Grade 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        41.6
      2. group Id
        OG001
        value
        49.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        747
      2. group Id
        OG001
        value
        735
      units
      Participants
    title
    Acute RT and Hormone Toxicity: Grade 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        16.1
      2. group Id
        OG001
        value
        25.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        747
      2. group Id
        OG001
        value
        735
      units
      Participants
    title
    Acute RT and Hormone Toxicity: Grade 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        747
      2. group Id
        OG001
        value
        735
      units
      Participants
    title
    Acute RT and Hormone Toxicity: Grade 4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        747
      2. group Id
        OG001
        value
        735
      units
      Participants
    title
    Acute RT and Hormone Toxicity: Grade 5
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        34.0
      2. group Id
        OG001
        value
        32.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        742
      2. group Id
        OG001
        value
        724
      units
      Participants
    title
    Late RT Toxicity: Grade 1
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        20.5
      2. group Id
        OG001
        value
        22.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        742
      2. group Id
        OG001
        value
        724
      units
      Participants
    title
    Late RT Toxicity: Grade 2
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        9.7
      2. group Id
        OG001
        value
        8.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        742
      2. group Id
        OG001
        value
        724
      units
      Participants
    title
    Late RT Toxicity: Grade 3
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0.1
      2. group Id
        OG001
        value
        0.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        742
      2. group Id
        OG001
        value
        724
      units
      Participants
    title
    Late RT Toxicity: Grade 4
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        742
      2. group Id
        OG001
        value
        724
      units
      Participants
    title
    Late RT Toxicity: Grade 5
denoms
  1. counts
    1. group Id
      OG000
      value
      747
    2. group Id
      OG001
      value
      735
    units
    Participants
description
Acute drug therapy and radiation (\<= 90 days from start of RT) toxicity was graded using the Common Toxicity Criteria (CTC) v.2.0 criteria; late toxicity was graded using the Radiation Therapy Oncology Group (RTOG)/European Organisation for Research and Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring schema. Grade refers to the severity of the toxicity. The CTC v2.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild toxicity, Grade 2 Moderate toxicity, Grade 3 Severe toxicity, Grade 4 Life-threatening or disabling toxicity, Grade 5 Death related to toxicity. The highest grade acute and late toxicity was determined for each patient.
groups
  1. description
    Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
    id
    OG000
    title
    TAS x 8 Weeks
  2. description
    TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
    id
    OG001
    title
    TAS x 28 Weeks
param Type
NUMBER
population Description
Eligible patients with adverse event data in corresponding time frame (during hormone therapy and \<=90 days from RT start; \> 90 days from RT start)
reporting Status
POSTED
time Frame
From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
title
Treatment-induced Morbidity (Highest Grade Toxicity Reported Per Patient)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice