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NCT00033631 · ADVERSE EVENTS

Adverse events

Radiation Therapy in Treating Patients With Stage II Prostate Cancer · Source last updated 2023-01-18

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

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Not reported
Other-event reporting threshold
5%

Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
70.2 Gy

70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.

30 / 744714 / 744Not reported / Not reported
79.2 Gy

79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 44 Fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.

43 / 737704 / 737Not reported / Not reported

Group identifiers: EG000: 70.2 Gy · EG001: 79.2 Gy

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      737
    term
    Left ventricular failure
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      737
    term
    Myocardial ischaemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      737
    term
    Abdominal pain NOS
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      737
    term
    Diarrhea (with colostomy)
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      737
    term
    Diarrhea NOS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      737
    term
    Late RT Toxicity: Bowel : NOS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      737
    term
    Late RT Toxicity: Other GI : NOS
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      737
    term
    Chest pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      737
    term
    Injection site reaction NOS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      737
    term
    Late RT Toxicity: Other : NOS
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      737
    term
    Pain due to radiation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      737
    term
    Pain-other

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      737
    term
    Diarrhea NOS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      90
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      128
      num At Risk
      737
    term
    Late RT Toxicity: Bowel : NOS
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      90
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      107
      num At Risk
      737
    term
    Late RT Toxicity: Other GI : NOS
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      737
    term
    Proctitis NOS
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      737
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      68
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      90
      num At Risk
      737
    term
    Late RT Toxicity: Other : NOS
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      737
    term
    Dysuria
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      99
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      126
      num At Risk
      737
    term
    Late RT Toxicity: Bladder/Other GU: NOS
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      566
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      585
      num At Risk
      737
    term
    Urinary frequency
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      234
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      229
      num At Risk
      737
    term
    Urinary incontinence
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      611
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      599
      num At Risk
      737
    term
    Impotence
Complete source fields
description
Eligible patients with toxicity data who did not withdraw consent. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
event Groups
  1. description
    70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
    id
    EG000
    other Num Affected
    714
    other Num At Risk
    744
    serious Num Affected
    30
    serious Num At Risk
    744
    title
    70.2 Gy
  2. description
    79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 44 Fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
    id
    EG001
    other Num Affected
    704
    other Num At Risk
    737
    serious Num Affected
    43
    serious Num At Risk
    737
    title
    79.2 Gy
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      737
    term
    Diarrhea NOS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      90
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      128
      num At Risk
      737
    term
    Late RT Toxicity: Bowel : NOS
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      90
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      107
      num At Risk
      737
    term
    Late RT Toxicity: Other GI : NOS
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      737
    term
    Proctitis NOS
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      737
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      68
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      90
      num At Risk
      737
    term
    Late RT Toxicity: Other : NOS
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      737
    term
    Dysuria
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      99
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      126
      num At Risk
      737
    term
    Late RT Toxicity: Bladder/Other GU: NOS
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      566
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      585
      num At Risk
      737
    term
    Urinary frequency
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      234
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      229
      num At Risk
      737
    term
    Urinary incontinence
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      611
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      599
      num At Risk
      737
    term
    Impotence
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      737
    term
    Left ventricular failure
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      737
    term
    Myocardial ischaemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      737
    term
    Abdominal pain NOS
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      737
    term
    Diarrhea (with colostomy)
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      737
    term
    Diarrhea NOS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      737
    term
    Late RT Toxicity: Bowel : NOS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      737
    term
    Late RT Toxicity: Other GI : NOS
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      737
    term
    Chest pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      737
    term
    Injection site reaction NOS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      737
    term
    Late RT Toxicity: Other : NOS
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      737
    term
    Pain due to radiation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      744
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      737
    term
    Pain-other

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