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NCT00680992 · ADVERSE EVENTS

Adverse events

Study of Denosumab in Subjects With Giant Cell Tumor of Bone · Source last updated 2022-09-22

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
From first dose of study drug until last study visit; a maximum of approximately 113 months. The planned study duration for each participant was at least 60 months (following protocol amendment 7).
Other-event reporting threshold
5%

Data are presented for the entire study duration and include AEs occurring during the treatment-emergent period (comprising both the initial treatment phase and retreatment phase) and AEs occurring after the treatment-emergent period (ie, during the safety follow-up phase).

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

All participants received denosumab 120 mg SC Q4W, starting on study day 1, with loading doses of 120 mg SC on days 8 and 15 in the first month of treatment for those enrolled in cohorts 1 or 2.

176 / 526480 / 52626 / 526

Group identifiers: EG000: Denosumab 120 mg Q4W (All Cohorts)

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 21.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      526
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      526
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      526
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      526
    term
    Microcytic anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      526
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      526
    term
    Bradycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      526
    term
    Cardiac failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      526
    term
    Coronary artery disease
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      526
    term
    Supraventricular tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      526
    term
    Aplasia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      526
    term
    Hyperparathyroidism
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      526
    term
    Toxic nodular goitre

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 21.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      526
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      526
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      526
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      526
    term
    Dental caries
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      526
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      122
      num At Risk
      526
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      68
      num At Risk
      526
    term
    Toothache
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      526
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      526
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      142
      num At Risk
      526
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      526
    term
    Influenza like illness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      526
    term
    Oedema peripheral
Complete source fields
description
Data are presented for the entire study duration and include AEs occurring during the treatment-emergent period (comprising both the initial treatment phase and retreatment phase) and AEs occurring after the treatment-emergent period (ie, during the safety follow-up phase).
event Groups
  1. deaths Num Affected
    26
    deaths Num At Risk
    526
    description
    All participants received denosumab 120 mg SC Q4W, starting on study day 1, with loading doses of 120 mg SC on days 8 and 15 in the first month of treatment for those enrolled in cohorts 1 or 2.
    id
    EG000
    other Num Affected
    480
    other Num At Risk
    526
    serious Num Affected
    176
    serious Num At Risk
    526
    title
    Denosumab 120 mg Q4W (All Cohorts)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      526
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      526
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      526
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      526
    term
    Dental caries
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      526
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      122
      num At Risk
      526
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      68
      num At Risk
      526
    term
    Toothache
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      526
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      526
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      142
      num At Risk
      526
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      526
    term
    Influenza like illness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      526
    term
    Oedema peripheral
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      526
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      526
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      526
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      526
    term
    Microcytic anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      526
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      526
    term
    Bradycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      526
    term
    Cardiac failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      526
    term
    Coronary artery disease
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      526
    term
    Supraventricular tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      526
    term
    Aplasia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      526
    term
    Hyperparathyroidism
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      526
    term
    Toxic nodular goitre
time Frame
From first dose of study drug until last study visit; a maximum of approximately 113 months. The planned study duration for each participant was at least 60 months (following protocol amendment 7).

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