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NCT01083849 · ADVERSE EVENTS

Adverse events

Long-Term Therapy Outcomes When Treating Chronic Kidney Disease (CKD) Patients With Paricalcitol in German and Austrian Clinical Practice · Source last updated 2014-12-19

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 (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded.
Other-event reporting threshold
5%

Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Paricalcitol Pre-dialysis Group

Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.

16 / 960 / 96Not reported / Not reported
Paricalcitol Dialysis Group

Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.

186 / 6370 / 637Not reported / Not reported

Group identifiers: EG000: Paricalcitol Pre-dialysis Group · EG001: Paricalcitol Dialysis Group

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      637
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      637
    term
    Haemorrhagic anaemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      637
    term
    Acute myocardial infarction
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      637
    term
    Angina pectoris
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      637
    term
    Aortic valve disease mixed
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      637
    term
    Aortic valve stenosis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      637
    term
    Arrhythmia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      637
    term
    Atrial fibrillation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      637
    term
    Cardiac arrest
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      637
    term
    Cardiac failure
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      637
    term
    Cardiac tamponade
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      637
    term
    Cardiopulmonary failure

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Complete source fields
    description
    Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
    event Groups
    1. description
      Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      96
      serious Num Affected
      16
      serious Num At Risk
      96
      title
      Paricalcitol Pre-dialysis Group
    2. description
      Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
      id
      EG001
      other Num Affected
      0
      other Num At Risk
      637
      serious Num Affected
      186
      serious Num At Risk
      637
      title
      Paricalcitol Dialysis Group
    frequency Threshold
    5
    serious Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      MedDRA 16.1
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        96
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        637
      term
      Anaemia
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      MedDRA 16.1
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        96
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        637
      term
      Haemorrhagic anaemia
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      MedDRA 16.1
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        96
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        637
      term
      Acute myocardial infarction
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      MedDRA 16.1
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        96
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        637
      term
      Angina pectoris
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      MedDRA 16.1
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        96
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        637
      term
      Aortic valve disease mixed
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      MedDRA 16.1
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        96
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        637
      term
      Aortic valve stenosis
    7. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      MedDRA 16.1
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        96
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        637
      term
      Arrhythmia
    8. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      MedDRA 16.1
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        96
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        637
      term
      Atrial fibrillation
    9. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      MedDRA 16.1
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        96
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        637
      term
      Cardiac arrest
    10. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      MedDRA 16.1
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        96
      2. group Id
        EG001
        num Affected
        5
        num At Risk
        637
      term
      Cardiac failure
    11. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      MedDRA 16.1
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        96
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        637
      term
      Cardiac tamponade
    12. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      MedDRA 16.1
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        96
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        637
      term
      Cardiopulmonary failure
    time Frame
    Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded.

    Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

    Preserved source evidence · Not medical advice