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NCT00002597 · ADVERSE EVENTS

Adverse events

Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer · Source last updated 2018-06-14

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 who received treatment. 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
Neoadjuvant TAS 2 Months Before and During RT

Neoadjuvant Total Androgen Suppression (TAS) two months before and during radiation therapy

33 / 1003975 / 1003Not reported / Not reported
Radiation Therapy Alone

Radiation therapy alone

16 / 1003955 / 1003Not reported / Not reported

Group identifiers: EG000: Neoadjuvant TAS 2 Months Before and During RT · EG001: Radiation Therapy Alone

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      1003
    term
    Acute RT Toxicity: Hematologic: NOS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    Coop. Group CTC 1989
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1003
    term
    Hormone Toxicity: Hematologic : NOS
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      1003
    term
    Late RT Toxicity: Hematologic: NOS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1003
    term
    Acute RT Toxicity: Bowel: NOS
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      1003
    term
    Late RT Toxicity: Bowel: NOS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1003
    term
    Late RT Toxicity: Other GI: NOS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1003
    term
    Late RT Toxicity: Other: NOS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    Coop. Group CTC 1989
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1003
    term
    Hormone Toxicity: Liver : NOS
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      1003
    term
    Acute RT Toxicity: Bladder: NOS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1003
    term
    Late RT Toxicity: Bladder: NOS
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1003
    term
    Late RT Toxicity: Other GU: NOS

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      127
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      67
      num At Risk
      1003
    term
    Acute RT Toxicity: Hematologic: NOS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    Coop. Group CTC 1989
    stats
    1. group Id
      EG000
      num Affected
      172
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1003
    term
    Hormone Toxicity: Hematologic : NOS
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      135
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      109
      num At Risk
      1003
    term
    Late RT Toxicity: Hematologic: NOS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      439
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      501
      num At Risk
      1003
    term
    Acute RT Toxicity: Bowel: NOS
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      262
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      210
      num At Risk
      1003
    term
    Late RT Toxicity: Bowel: NOS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      135
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      138
      num At Risk
      1003
    term
    Acute RT Toxicity: Other: NOS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      84
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      99
      num At Risk
      1003
    term
    Late RT Toxicity: Other: NOS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    Coop. Group CTC 1989
    stats
    1. group Id
      EG000
      num Affected
      93
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1003
    term
    Hormone Toxicity: Liver : NOS
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      149
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      190
      num At Risk
      1003
    term
    Acute RT Toxicity: Bladder: NOS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      182
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      166
      num At Risk
      1003
    term
    Late RT Toxicity: Bladder: NOS
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    Coop. Group CTC 1989
    stats
    1. group Id
      EG000
      num Affected
      238
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1003
    term
    Hormone Toxicity: Impotence : NOS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      78
      num At Risk
      1003
    term
    Late RT Toxicity: Other GU: NOS
Complete source fields
description
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
event Groups
  1. description
    Neoadjuvant Total Androgen Suppression (TAS) two months before and during radiation therapy
    id
    EG000
    other Num Affected
    975
    other Num At Risk
    1003
    serious Num Affected
    33
    serious Num At Risk
    1003
    title
    Neoadjuvant TAS 2 Months Before and During RT
  2. description
    Radiation therapy alone
    id
    EG001
    other Num Affected
    955
    other Num At Risk
    1003
    serious Num Affected
    16
    serious Num At Risk
    1003
    title
    Radiation Therapy Alone
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      127
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      67
      num At Risk
      1003
    term
    Acute RT Toxicity: Hematologic: NOS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    Coop. Group CTC 1989
    stats
    1. group Id
      EG000
      num Affected
      172
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1003
    term
    Hormone Toxicity: Hematologic : NOS
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      135
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      109
      num At Risk
      1003
    term
    Late RT Toxicity: Hematologic: NOS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      439
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      501
      num At Risk
      1003
    term
    Acute RT Toxicity: Bowel: NOS
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      262
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      210
      num At Risk
      1003
    term
    Late RT Toxicity: Bowel: NOS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      135
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      138
      num At Risk
      1003
    term
    Acute RT Toxicity: Other: NOS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      84
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      99
      num At Risk
      1003
    term
    Late RT Toxicity: Other: NOS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    Coop. Group CTC 1989
    stats
    1. group Id
      EG000
      num Affected
      93
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1003
    term
    Hormone Toxicity: Liver : NOS
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      149
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      190
      num At Risk
      1003
    term
    Acute RT Toxicity: Bladder: NOS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      182
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      166
      num At Risk
      1003
    term
    Late RT Toxicity: Bladder: NOS
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    Coop. Group CTC 1989
    stats
    1. group Id
      EG000
      num Affected
      238
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1003
    term
    Hormone Toxicity: Impotence : NOS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      78
      num At Risk
      1003
    term
    Late RT Toxicity: Other GU: NOS
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      1003
    term
    Acute RT Toxicity: Hematologic: NOS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    Coop. Group CTC 1989
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1003
    term
    Hormone Toxicity: Hematologic : NOS
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      1003
    term
    Late RT Toxicity: Hematologic: NOS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1003
    term
    Acute RT Toxicity: Bowel: NOS
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      1003
    term
    Late RT Toxicity: Bowel: NOS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1003
    term
    Late RT Toxicity: Other GI: NOS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1003
    term
    Late RT Toxicity: Other: NOS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    Coop. Group CTC 1989
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1003
    term
    Hormone Toxicity: Liver : NOS
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      1003
    term
    Acute RT Toxicity: Bladder: NOS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1003
    term
    Late RT Toxicity: Bladder: NOS
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1003
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1003
    term
    Late RT Toxicity: Other GU: NOS

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