Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00002874 · ADVERSE EVENTS

Adverse events

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.

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%

Subjects who started protocol treatment are included. Subjects experiencing more than one of a given toxicity are counted only once for that toxicity. Adverse events were graded with a combination of the Cooperative Group Common Toxicity Criteria and RTOG Acute and Late Radiation Morbidity Scoring. Grade refers to severity of toxicity assigning Grades 1-5: Grade 0 None, Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related toxicity.

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

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

84 / 382346 / 382Not reported / Not reported
Bicalutamide

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

97 / 374374 / 374Not reported / Not reported

Group identifiers: EG000: Placebo · EG001: Bicalutamide

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
    Coop. Group CTC
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      374
    term
    Acute RT Toxicity: Hematologic: NOS
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      374
    term
    Hematologic: NOS
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      374
    term
    Cardiac: NOS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Coop. Group CTC
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      374
    term
    Acute RT Toxicity: Bowel: NOS
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      374
    term
    Bowel/GI: NOS
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      374
    term
    Nausea/vomiting: NOS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    Coop. Group CTC
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      374
    term
    Acute RT Toxicity: Other: NOS
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      374
    term
    Other: NOS
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      374
    term
    Pain: NOS
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      374
    term
    Liver: NOS
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      374
    term
    Neurologic: NOS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    Coop. Group CTC
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      374
    term
    Acute RT Toxicity: Bladder: 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
    Coop. Group CTC
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      374
    term
    Acute RT Toxicity: Hematologic: NOS
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      374
    term
    Hematologic: NOS
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      374
    term
    Cardiac: NOS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Coop. Group CTC
    stats
    1. group Id
      EG000
      num Affected
      232
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      235
      num At Risk
      374
    term
    Acute RT Toxicity: Bowel: NOS
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      192
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      168
      num At Risk
      374
    term
    Bowel/GI: NOS
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      374
    term
    Nausea/vomiting: NOS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    Coop. Group CTC
    stats
    1. group Id
      EG000
      num Affected
      68
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      374
    term
    Acute RT Toxicity: Other: NOS
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      129
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      100
      num At Risk
      374
    term
    Other: NOS
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      374
    term
    Pain: NOS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    Coop. Group CTC
    stats
    1. group Id
      EG000
      num Affected
      87
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      88
      num At Risk
      374
    term
    Acute RT Toxicity: Skin: NOS
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      374
    term
    Skin-within XRT field: NOS
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      374
    term
    Neurologic: NOS
Complete source fields
description
Subjects who started protocol treatment are included. Subjects experiencing more than one of a given toxicity are counted only once for that toxicity. Adverse events were graded with a combination of the Cooperative Group Common Toxicity Criteria and RTOG Acute and Late Radiation Morbidity Scoring. Grade refers to severity of toxicity assigning Grades 1-5: Grade 0 None, Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related toxicity.
event Groups
  1. description
    Radiation therapy (64.8 Gy) + placebo (daily 2 years)
    id
    EG000
    other Num Affected
    346
    other Num At Risk
    382
    serious Num Affected
    84
    serious Num At Risk
    382
    title
    Placebo
  2. description
    Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
    id
    EG001
    other Num Affected
    374
    other Num At Risk
    374
    serious Num Affected
    97
    serious Num At Risk
    374
    title
    Bicalutamide
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    Coop. Group CTC
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      374
    term
    Acute RT Toxicity: Hematologic: NOS
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      374
    term
    Hematologic: NOS
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      374
    term
    Cardiac: NOS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Coop. Group CTC
    stats
    1. group Id
      EG000
      num Affected
      232
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      235
      num At Risk
      374
    term
    Acute RT Toxicity: Bowel: NOS
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      192
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      168
      num At Risk
      374
    term
    Bowel/GI: NOS
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      374
    term
    Nausea/vomiting: NOS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    Coop. Group CTC
    stats
    1. group Id
      EG000
      num Affected
      68
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      374
    term
    Acute RT Toxicity: Other: NOS
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      129
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      100
      num At Risk
      374
    term
    Other: NOS
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      374
    term
    Pain: NOS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    Coop. Group CTC
    stats
    1. group Id
      EG000
      num Affected
      87
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      88
      num At Risk
      374
    term
    Acute RT Toxicity: Skin: NOS
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      374
    term
    Skin-within XRT field: NOS
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      374
    term
    Neurologic: NOS
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    Coop. Group CTC
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      374
    term
    Acute RT Toxicity: Hematologic: NOS
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      374
    term
    Hematologic: NOS
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      374
    term
    Cardiac: NOS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    Coop. Group CTC
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      374
    term
    Acute RT Toxicity: Bowel: NOS
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      374
    term
    Bowel/GI: NOS
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      374
    term
    Nausea/vomiting: NOS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    Coop. Group CTC
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      374
    term
    Acute RT Toxicity: Other: NOS
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      374
    term
    Other: NOS
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      374
    term
    Pain: NOS
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      374
    term
    Liver: NOS
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    RTOG Acute RT Morb.
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      374
    term
    Neurologic: NOS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    Coop. Group CTC
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      382
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      374
    term
    Acute RT Toxicity: Bladder: NOS

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

Preserved source evidence · Not medical advice