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NCT00896454 · ADVERSE EVENTS

Adverse events

Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium · Source last updated 2018-10-17

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
Median time on study was 1.8 months.
Other-event reporting threshold
5%

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Denosumab 120 mg Q4W

Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.

29 / 3326 / 33Not reported / Not reported

Group identifiers: EG000: Denosumab 120 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 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    term
    Pancytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    term
    Cardiac arrest
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
    term
    Tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    term
    Hypercalcaemia of malignancy
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    term
    Colitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    term
    Oesophageal obstruction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    term
    Pyrexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    term
    Hepatic failure

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 15.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      33
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      33
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      33
    term
    Abdominal distension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      33
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      33
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      33
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
    term
    Dry mouth
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      33
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      33
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
    term
    Asthenia
Complete source fields
description
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
event Groups
  1. description
    Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
    id
    EG000
    other Num Affected
    26
    other Num At Risk
    33
    serious Num Affected
    29
    serious Num At Risk
    33
    title
    Denosumab 120 mg Q4W
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      33
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      33
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      33
    term
    Abdominal distension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      33
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      33
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      33
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
    term
    Dry mouth
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      33
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      33
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
    term
    Asthenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    term
    Pancytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    term
    Cardiac arrest
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
    term
    Tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    term
    Hypercalcaemia of malignancy
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    term
    Colitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    term
    Oesophageal obstruction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    term
    Pyrexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    term
    Hepatic failure
time Frame
Median time on study was 1.8 months.

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