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NCT00259740 · ADVERSE EVENTS

Adverse events

Open-Label, Phase 2, Proof of Concept Study in Multiple Myeloma - Denosumab · Source last updated 2017-03-15

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 the most frequent non-serious occurrences of adverse events.

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

Not reported

14 / 5338 / 53Not reported / Not reported
Denosumab 120 mg Q4W - Plateau-Phase

Not reported

6 / 4232 / 42Not reported / Not reported

Group identifiers: EG000: Denosumab 120 mg Q4W - Relapsed · EG001: Denosumab 120 mg Q4W - Plateau-Phase

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 9.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Cardiac failure congestive
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Coronary artery stenosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Gastritis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Intestinal obstruction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Intestinal perforation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Pneumoperitoneum
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Chest pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Bronchitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Catheter related infection

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 9.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      42
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      42
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      42
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      42
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Stomatitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Asthenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      42
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      42
    term
    Oedema peripheral
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Pyrexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      42
    term
    Nasopharyngitis
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
    38
    other Num At Risk
    53
    serious Num Affected
    14
    serious Num At Risk
    53
    title
    Denosumab 120 mg Q4W - Relapsed
  2. id
    EG001
    other Num Affected
    32
    other Num At Risk
    42
    serious Num Affected
    6
    serious Num At Risk
    42
    title
    Denosumab 120 mg Q4W - Plateau-Phase
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      42
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      42
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      42
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      42
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Stomatitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Asthenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      42
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      42
    term
    Oedema peripheral
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Pyrexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      42
    term
    Nasopharyngitis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Cardiac failure congestive
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Coronary artery stenosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Gastritis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Intestinal obstruction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Intestinal perforation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Pneumoperitoneum
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Chest pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Bronchitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Catheter related infection
time Frame
up to 1 year 6 months

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