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NCT00396279 · ADVERSE EVENTS

Adverse events

Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable Giant Cell Tumor of Bone · Source last updated 2022-11-08

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
up to 1 year 6 months
Other-event reporting threshold
5%

The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.

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

Participants received a dose loading regimen of 3 subcutaneous injections of denosumab 120 mg every week for 3 weeks (study Days 1, 8, and 15), followed by a week of rest, and then 120 mg denosumab once every 4 weeks (Q4W) from Day 29.

5 / 3725 / 37Not 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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    term
    Nausea
  2. 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
      37
    term
    Lower respiratory tract infection
  3. 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
      37
    term
    Pneumonia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    term
    Ankle fracture
  5. 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
      37
    term
    Back pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    term
    Metastases to lung
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    term
    Depression
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    term
    Acute respiratory distress syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    term
    Dyspnoea

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    term
    Constipation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    term
    Asthenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    term
    Bronchitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    term
    Influenza
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
    term
    Nasopharyngitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    term
    Upper respiratory tract infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    term
    Anorexia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    term
    Hypocalcaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    term
    Hypophosphataemia
Complete source fields
description
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.
event Groups
  1. description
    Participants received a dose loading regimen of 3 subcutaneous injections of denosumab 120 mg every week for 3 weeks (study Days 1, 8, and 15), followed by a week of rest, and then 120 mg denosumab once every 4 weeks (Q4W) from Day 29.
    id
    EG000
    other Num Affected
    25
    other Num At Risk
    37
    serious Num Affected
    5
    serious Num At Risk
    37
    title
    Denosumab 120 mg Q4W
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    term
    Constipation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    term
    Asthenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    term
    Bronchitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    term
    Influenza
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
    term
    Nasopharyngitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    term
    Upper respiratory tract infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    term
    Anorexia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    term
    Hypocalcaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    term
    Hypophosphataemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    term
    Nausea
  2. 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
      37
    term
    Lower respiratory tract infection
  3. 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
      37
    term
    Pneumonia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    term
    Ankle fracture
  5. 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
      37
    term
    Back pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    term
    Metastases to lung
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    term
    Depression
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    term
    Acute respiratory distress syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    term
    Dyspnoea
time Frame
up to 1 year 6 months

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