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NCT00005044 · ADVERSE EVENTS

Adverse events

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.

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 adverse event data are included. 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
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).

121 / 747695 / 747Not reported / Not reported
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).

109 / 735707 / 735Not reported / Not reported

Group identifiers: EG000: TAS x 8 Weeks · EG001: TAS x 28 Weeks

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
      1
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      735
    term
    Arrhythmia NOS
  2. 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
      747
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      735
    term
    Supraventricular arrhythmia NOS
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      735
    term
    Diarrhea 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
      747
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      735
    term
    Gastritis NOS
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      735
    term
    Late RT Toxicity: Other GI: NOS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      735
    term
    Late RT Toxicity: Small/Large Intestine: NOS
  7. 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
      747
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      735
    term
    Proctalgia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      735
    term
    Proctitis NOS
  9. 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
      747
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      735
    term
    Vomiting NOS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      735
    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
      1
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      735
    term
    Pain-other
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      735
    term
    Hepatic-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
      25
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      735
    term
    Constipation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      238
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      245
      num At Risk
      735
    term
    Diarrhea NOS
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      135
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      159
      num At Risk
      735
    term
    Late RT Toxicity: Other GI: NOS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      194
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      196
      num At Risk
      735
    term
    Late RT Toxicity: Small/Large Intestine: NOS
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      173
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      164
      num At Risk
      735
    term
    Proctitis NOS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      113
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      124
      num At Risk
      735
    term
    Late RT Toxicity: Other: NOS
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      159
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      224
      num At Risk
      735
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      103
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      89
      num At Risk
      735
    term
    Dermatitis radiation NOS
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      92
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      104
      num At Risk
      735
    term
    Alanine aminotransferase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      735
    term
    Blood bilirubin increased
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      735
    term
    Libido decreased
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      85
      num At Risk
      735
    term
    Dysuria
Complete source fields
description
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
event 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
    EG000
    other Num Affected
    695
    other Num At Risk
    747
    serious Num Affected
    121
    serious Num At Risk
    747
    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
    EG001
    other Num Affected
    707
    other Num At Risk
    735
    serious Num Affected
    109
    serious Num At Risk
    735
    title
    TAS x 28 Weeks
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
      25
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      735
    term
    Constipation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      238
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      245
      num At Risk
      735
    term
    Diarrhea NOS
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      135
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      159
      num At Risk
      735
    term
    Late RT Toxicity: Other GI: NOS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      194
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      196
      num At Risk
      735
    term
    Late RT Toxicity: Small/Large Intestine: NOS
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      173
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      164
      num At Risk
      735
    term
    Proctitis NOS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      113
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      124
      num At Risk
      735
    term
    Late RT Toxicity: Other: NOS
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      159
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      224
      num At Risk
      735
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      103
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      89
      num At Risk
      735
    term
    Dermatitis radiation NOS
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      92
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      104
      num At Risk
      735
    term
    Alanine aminotransferase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      735
    term
    Blood bilirubin increased
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      735
    term
    Libido decreased
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      85
      num At Risk
      735
    term
    Dysuria
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      735
    term
    Arrhythmia NOS
  2. 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
      747
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      735
    term
    Supraventricular arrhythmia NOS
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      735
    term
    Diarrhea 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
      747
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      735
    term
    Gastritis NOS
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      735
    term
    Late RT Toxicity: Other GI: NOS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      735
    term
    Late RT Toxicity: Small/Large Intestine: NOS
  7. 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
      747
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      735
    term
    Proctalgia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      735
    term
    Proctitis NOS
  9. 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
      747
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      735
    term
    Vomiting NOS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      735
    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
      1
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      735
    term
    Pain-other
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      747
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      735
    term
    Hepatic-Other

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