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NCT03301857 · ADVERSE EVENTS

Adverse events

Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004 · Source last updated 2024-05-20

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 Approximately 5 years
Other-event reporting threshold
5%

FAS included all enrolled participants (from study 20062004) who provided informed consent and had a non-missing enrolment date in this study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Exposed to IP

Subjects treated with study IP

8 / 5137 / 510 / 51
Not Exposed to IP

Subjects not treated with study IP

0 / 340 / 342 / 34

Group identifiers: EG000: Exposed to IP · EG001: Not Exposed to IP

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 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Anal fistula
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Gastrointestinal obstruction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Medical device site infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Sepsis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Viral pericarditis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Femur fracture
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Patella fracture
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Myositis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Osteonecrosis of jaw
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Osteosarcoma

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 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Toothache
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Pyrexia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    COVID-19
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Gingivitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Sinusitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Foot fracture
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Hypocalcaemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Arthralgia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Back pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Myalgia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Osteonecrosis of jaw
Complete source fields
description
FAS included all enrolled participants (from study 20062004) who provided informed consent and had a non-missing enrolment date in this study.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    51
    description
    Subjects treated with study IP
    id
    EG000
    other Num Affected
    37
    other Num At Risk
    51
    serious Num Affected
    8
    serious Num At Risk
    51
    title
    Exposed to IP
  2. deaths Num Affected
    2
    deaths Num At Risk
    34
    description
    Subjects not treated with study IP
    id
    EG001
    other Num Affected
    0
    other Num At Risk
    34
    serious Num Affected
    0
    serious Num At Risk
    34
    title
    Not Exposed to IP
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Toothache
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Pyrexia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    COVID-19
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Gingivitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Sinusitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Foot fracture
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Hypocalcaemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Arthralgia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Back pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Myalgia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Osteonecrosis of jaw
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Anal fistula
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Gastrointestinal obstruction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Medical device site infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Sepsis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Viral pericarditis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Femur fracture
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Patella fracture
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Myositis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Osteonecrosis of jaw
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Osteosarcoma
time Frame
Up to Approximately 5 years

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