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NCT01083849 · OUTCOME

Number of Participants With Hypercalcemia

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.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Months 0, 3, 6, 9, and 12

What was measured

Hypercalcemia was defined as having a serum calcium level greater than 11.2 mg/dL (2.79 mmol/L), in one measurement. Serum calcium was measured at every study visit.

Analysis population: The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.

Groups in this outcome

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, prescribed on an on-label basis in an everyday setting. Participants were observed for 12 months.

Paricalcitol Dialysis Group

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Paricalcitol Pre-dialysis Group96
Paricalcitol Dialysis Group637

Reported measurements

Month 0
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paricalcitol Pre-dialysis Group1Not reportedNot reportedNot reportedNot reported
Paricalcitol Dialysis Group2Not reportedNot reportedNot reportedNot reported
Month 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paricalcitol Pre-dialysis Group2Not reportedNot reportedNot reportedNot reported
Paricalcitol Dialysis Group6Not reportedNot reportedNot reportedNot reported
Month 6
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paricalcitol Pre-dialysis Group1Not reportedNot reportedNot reportedNot reported
Paricalcitol Dialysis Group4Not reportedNot reportedNot reportedNot reported
Month 9
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paricalcitol Pre-dialysis Group1Not reportedNot reportedNot reportedNot reported
Paricalcitol Dialysis Group4Not reportedNot reportedNot reportedNot reported
Month 12
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paricalcitol Pre-dialysis Group1Not reportedNot reportedNot reportedNot reported
Paricalcitol Dialysis Group5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
    title
    Month 0
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        6
    title
    Month 3
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        4
    title
    Month 6
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        4
    title
    Month 9
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        5
    title
    Month 12
denoms
  1. counts
    1. group Id
      OG000
      value
      96
    2. group Id
      OG001
      value
      637
    units
    Participants
description
Hypercalcemia was defined as having a serum calcium level greater than 11.2 mg/dL (2.79 mmol/L), in one measurement. Serum calcium was measured at every study visit.
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, prescribed on an on-label basis in an everyday setting. Participants were observed for 12 months.
    id
    OG000
    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, prescribed on an on-label basis in an everyday setting. Participants were observed for 12 months.
    id
    OG001
    title
    Paricalcitol Dialysis Group
param Type
NUMBER
population Description
The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.
reporting Status
POSTED
time Frame
Months 0, 3, 6, 9, and 12
title
Number of Participants With Hypercalcemia
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice