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NCT00104650 · ADVERSE EVENTS

Adverse events

Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous (IV) Bisphosphonates · Source last updated 2011-01-24

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
25 weeks
Other-event reporting threshold
5%

The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Bisphosphonate IV Q4W

Not reported

19 / 3533 / 35Not reported / Not reported
Denosumab 180 mg Q12W

Not reported

16 / 3529 / 35Not reported / Not reported
Denosumab 180 mg Q4W

Not reported

21 / 3829 / 38Not reported / Not reported

Group identifiers: EG000: Bisphosphonate IV Q4W · EG001: Denosumab 180 mg Q12W · EG002: Denosumab 180 mg Q4W

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 10.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      38
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
    term
    Bone marrow failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Coagulopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      38
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      38
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Cardio-respiratory arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
    term
    Cardiopulmonary failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
    term
    Pericardial effusion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Sinus bradycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Diplopia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Abdominal distension

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 10.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      38
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      38
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      38
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
    term
    Angina pectoris
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      38
    term
    Sinus tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      38
    term
    Vertigo
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
    term
    Conjunctivitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      38
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      38
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      38
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Gastritis
Complete source fields
description
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
event Groups
  1. id
    EG000
    other Num Affected
    33
    other Num At Risk
    35
    serious Num Affected
    19
    serious Num At Risk
    35
    title
    Bisphosphonate IV Q4W
  2. id
    EG001
    other Num Affected
    29
    other Num At Risk
    35
    serious Num Affected
    16
    serious Num At Risk
    35
    title
    Denosumab 180 mg Q12W
  3. id
    EG002
    other Num Affected
    29
    other Num At Risk
    38
    serious Num Affected
    21
    serious Num At Risk
    38
    title
    Denosumab 180 mg Q4W
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      38
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      38
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      38
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
    term
    Angina pectoris
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      38
    term
    Sinus tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      38
    term
    Vertigo
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
    term
    Conjunctivitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      38
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      38
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      38
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Gastritis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      38
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
    term
    Bone marrow failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Coagulopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      38
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      38
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Cardio-respiratory arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
    term
    Cardiopulmonary failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
    term
    Pericardial effusion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Sinus bradycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Diplopia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Abdominal distension
time Frame
25 weeks

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