Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00467844 · ADVERSE EVENTS

Adverse events

Study of GTx-024 on Muscle Wasting (Cachexia) Cancer. · Source last updated 2014-07-11

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%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
GTx -024

1 mg

14 / 5347 / 53Not reported / Not reported
GTx-024

3 mg

15 / 5449 / 54Not reported / Not reported
3 mg of Placebo

Placebo

17 / 5246 / 52Not reported / Not reported

Group identifiers: EG000: GTx -024 · EG001: GTx-024 · EG002: 3 mg of Placebo

Serious adverse events

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

  1. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Anaemia
  2. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      52
    term
    Febrile Neutropenia
  3. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Neutropenia
  4. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    term
    Pancytopenia
  5. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Thrombocytopenia
  6. organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Atrial Fibrillation
  7. organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Myocardial infarction
  8. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Diarrhoea
  9. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    term
    Dysphagia
  10. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    term
    gastric ulcer perforation
  11. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    lower gastrointestinal haemorrhage
  12. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    term
    pancreatitis

Other reported adverse events

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

  1. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      54
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      52
    term
    anaemia
  2. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      54
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      52
    term
    neutropenia
  3. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      54
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      52
    term
    thrombocytopenia
  4. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      54
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      52
    term
    abdominal pain
  5. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      54
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      52
    term
    constipation
  6. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      54
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      52
    term
    diarrhoea
  7. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      54
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      52
    term
    vomiting
  8. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      54
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      52
    term
    asthenia
  9. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      54
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      52
    term
    fatigue
  10. organ System
    General disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      54
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      52
    term
    pyrexia
  11. organ System
    Infections and infestations
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      54
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      52
    term
    pneumonia
  12. organ System
    Investigations
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      54
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      52
    term
    weight decreased
Complete source fields
event Groups
  1. description
    1 mg
    id
    EG000
    other Num Affected
    47
    other Num At Risk
    53
    serious Num Affected
    14
    serious Num At Risk
    53
    title
    GTx -024
  2. description
    3 mg
    id
    EG001
    other Num Affected
    49
    other Num At Risk
    54
    serious Num Affected
    15
    serious Num At Risk
    54
    title
    GTx-024
  3. description
    Placebo
    id
    EG002
    other Num Affected
    46
    other Num At Risk
    52
    serious Num Affected
    17
    serious Num At Risk
    52
    title
    3 mg of Placebo
frequency Threshold
5
other Events
  1. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      54
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      52
    term
    anaemia
  2. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      54
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      52
    term
    neutropenia
  3. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      54
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      52
    term
    thrombocytopenia
  4. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      54
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      52
    term
    abdominal pain
  5. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      54
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      52
    term
    constipation
  6. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      54
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      52
    term
    diarrhoea
  7. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      54
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      52
    term
    vomiting
  8. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      54
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      52
    term
    asthenia
  9. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      54
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      52
    term
    fatigue
  10. organ System
    General disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      54
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      52
    term
    pyrexia
  11. organ System
    Infections and infestations
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      54
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      52
    term
    pneumonia
  12. organ System
    Investigations
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      54
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      52
    term
    weight decreased
serious Events
  1. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Anaemia
  2. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      52
    term
    Febrile Neutropenia
  3. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Neutropenia
  4. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    term
    Pancytopenia
  5. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Thrombocytopenia
  6. organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Atrial Fibrillation
  7. organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Myocardial infarction
  8. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Diarrhoea
  9. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    term
    Dysphagia
  10. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    term
    gastric ulcer perforation
  11. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    lower gastrointestinal haemorrhage
  12. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    term
    pancreatitis

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice