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NCT00002874 · OUTCOME

Grade 3+ Toxicity

Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy · 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
participants
Interval / dispersion
Not reported
Time frame
From date of randomization to four years.

What was measured

Adverse events are graded using the Cooperative Group Common Toxicity Criteria and the Radiation Therapy Oncology Group (RTOG) Radiation Morbidity Scoring. Grade refers to severity, assigning Grades 1 through 5 based on this general guideline: Grade 0 None, Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related toxicity. Toxicities reported to have occurred within 90 days from the start of radiotherapy are reported as "Acute Radiotherapy", all later toxicities are reported as "Hormone therapy and late radiotherapy toxicity". The highest grade toxicity event per subject is counted within each of these time periods. Four-year follow-up was required of all patients; patients are followed until death.

Analysis population: Eligible patients who started protocol treatment and did not withdraw consent.

Groups in this outcome

Placebo

Radiation therapy (64.8 Gy) + placebo (daily 2 years)

Bicalutamide

Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)

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

Analysis denominator · Participants

GroupSource count
Placebo374
Bicalutamide382

Reported measurements

Acute radiotherapy toxicity
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo17Not reportedNot reportedNot reportedNot reported
Bicalutamide8Not reportedNot reportedNot reportedNot reported
Hormone therapy and late radiotherapy toxicity
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo73Not reportedNot reportedNot reportedNot reported
Bicalutamide100Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Description
    Acute radiotherapy toxicity
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.060
    statistical Method
    Chi-squared
  2. group Description
    Hormone therapy and late radiotherapy toxicity
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.029
    statistical Method
    Chi-squared
Complete source fields
analyses
  1. group Description
    Acute radiotherapy toxicity
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.060
    statistical Method
    Chi-squared
  2. group Description
    Hormone therapy and late radiotherapy toxicity
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.029
    statistical Method
    Chi-squared
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        8
    title
    Acute radiotherapy toxicity
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        73
      2. group Id
        OG001
        value
        100
    title
    Hormone therapy and late radiotherapy toxicity
denoms
  1. counts
    1. group Id
      OG000
      value
      374
    2. group Id
      OG001
      value
      382
    units
    Participants
description
Adverse events are graded using the Cooperative Group Common Toxicity Criteria and the Radiation Therapy Oncology Group (RTOG) Radiation Morbidity Scoring. Grade refers to severity, assigning Grades 1 through 5 based on this general guideline: Grade 0 None, Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related toxicity. Toxicities reported to have occurred within 90 days from the start of radiotherapy are reported as "Acute Radiotherapy", all later toxicities are reported as "Hormone therapy and late radiotherapy toxicity". The highest grade toxicity event per subject is counted within each of these time periods. Four-year follow-up was required of all patients; patients are followed until death.
groups
  1. description
    Radiation therapy (64.8 Gy) + placebo (daily 2 years)
    id
    OG000
    title
    Placebo
  2. description
    Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
    id
    OG001
    title
    Bicalutamide
param Type
NUMBER
population Description
Eligible patients who started protocol treatment and did not withdraw consent.
reporting Status
POSTED
time Frame
From date of randomization to four years.
title
Grade 3+ Toxicity
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice