Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00005947 · ADVERSE EVENTS

Adverse events

Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy · Source last updated 2010-11-01

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
4 years, 8 months
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Sipuleucel-T

All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.

22 / 8282 / 82Not reported / Not reported
Placebo

All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure.

8 / 4544 / 45Not reported / Not reported

Group identifiers: EG000: Sipuleucel-T · EG001: Placebo

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
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Aortic valve incompetence
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Aphasia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Arrhythmia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Atrioventricular block
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Back pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Bacteraemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Bladder Obstruction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Blood creatinine increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Cardiac failure congestive
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Catheter related infection

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
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      45
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      45
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      45
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      45
    term
    Dyspepsia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      45
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Asthenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      45
    term
    Chills
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      45
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Feeling cold
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Influenza like illness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      45
    term
    Oedema peripheral
Complete source fields
event Groups
  1. description
    All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.
    id
    EG000
    other Num Affected
    82
    other Num At Risk
    82
    serious Num Affected
    22
    serious Num At Risk
    82
    title
    Sipuleucel-T
  2. description
    All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure.
    id
    EG001
    other Num Affected
    44
    other Num At Risk
    45
    serious Num Affected
    8
    serious Num At Risk
    45
    title
    Placebo
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      45
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      45
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      45
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      45
    term
    Dyspepsia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      45
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Asthenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      45
    term
    Chills
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      45
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Feeling cold
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Influenza like illness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      45
    term
    Oedema peripheral
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Aortic valve incompetence
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Aphasia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Arrhythmia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Atrioventricular block
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Back pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Bacteraemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
    term
    Bladder Obstruction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Blood creatinine increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Cardiac failure congestive
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
    term
    Catheter related infection
time Frame
4 years, 8 months

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

Preserved source evidence · Not medical advice