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NCT03027557 · ADVERSE EVENTS

Adverse events

Treatment of Primary Hyperparathyroidism With Denosumab and Cinacalcet. · Source last updated 2021-05-25

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
Adverse events were collected for each participant from baseline until two weeks after treatment-cessation, up to 1 year.
Other-event reporting threshold
5%

Adverse events were collected at each visit using a adverse event questionnaire as well as assessment by a study-physician.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Combined Treatment.

15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.

2 / 1513 / 150 / 15
Denosumab Monotherapy

16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.

1 / 1615 / 160 / 16
Placebo

15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.

3 / 1515 / 150 / 15

Group identifiers: EG000: Combined Treatment. · EG001: Denosumab Monotherapy · EG002: Placebo

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Angina, Unstable
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
      num Events
      0
    term
    Polycythaemia Vera
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
      num Events
      0
    term
    Epilepsy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
      num Events
      0
    term
    Inflammatory Bowel Disease
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Gastritis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Erysipelas

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
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
      num Events
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
      num Events
      0
    term
    Leg edema
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      16
      num Events
      9
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      15
      num Events
      2
    term
    Coughing
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
      num Events
      0
    term
    Dyspnea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      15
      num Events
      36
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
      num Events
      15
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      15
      num Events
      20
    term
    Paraesthesia, hands
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      15
      num Events
      17
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
      num Events
      27
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      15
      num Events
      23
    term
    Paraesthesia, feet
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Headache
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      15
      num Events
      5
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      16
      num Events
      7
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      15
      num Events
      17
    term
    Dizziness
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      15
      num Events
      18
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      16
      num Events
      21
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      15
      num Events
      5
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
      num Events
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      15
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      15
      num Events
      2
    term
    Gastroenteritis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
      num Events
      0
    term
    Cystitis
Complete source fields
description
Adverse events were collected at each visit using a adverse event questionnaire as well as assessment by a study-physician.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    15
    description
    15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.
    id
    EG000
    other Num Affected
    13
    other Num At Risk
    15
    serious Num Affected
    2
    serious Num At Risk
    15
    title
    Combined Treatment.
  2. deaths Num Affected
    0
    deaths Num At Risk
    16
    description
    16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.
    id
    EG001
    other Num Affected
    15
    other Num At Risk
    16
    serious Num Affected
    1
    serious Num At Risk
    16
    title
    Denosumab Monotherapy
  3. deaths Num Affected
    0
    deaths Num At Risk
    15
    description
    15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.
    id
    EG002
    other Num Affected
    15
    other Num At Risk
    15
    serious Num Affected
    3
    serious Num At Risk
    15
    title
    Placebo
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
      num Events
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
      num Events
      0
    term
    Leg edema
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      16
      num Events
      9
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      15
      num Events
      2
    term
    Coughing
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
      num Events
      0
    term
    Dyspnea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      15
      num Events
      36
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
      num Events
      15
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      15
      num Events
      20
    term
    Paraesthesia, hands
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      15
      num Events
      17
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
      num Events
      27
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      15
      num Events
      23
    term
    Paraesthesia, feet
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Headache
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      15
      num Events
      5
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      16
      num Events
      7
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      15
      num Events
      17
    term
    Dizziness
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      15
      num Events
      18
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      16
      num Events
      21
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      15
      num Events
      5
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
      num Events
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      15
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      15
      num Events
      2
    term
    Gastroenteritis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
      num Events
      0
    term
    Cystitis
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Angina, Unstable
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
      num Events
      0
    term
    Polycythaemia Vera
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
      num Events
      0
    term
    Epilepsy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
      num Events
      0
    term
    Inflammatory Bowel Disease
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Gastritis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Erysipelas
time Frame
Adverse events were collected for each participant from baseline until two weeks after treatment-cessation, up to 1 year.

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