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NCT00896454 · OUTCOME

Percentage of Participants With a Response by Visit

Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium · Source last updated 2018-10-17

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Days 2, 4, 8, 10, 15, 19, 23, 29, 36, 43, 50 and 57

What was measured

Response is defined as corrected serum calcium (CSC) ≤ 11.5 mg/dL, within 10 days after the first dose of denosumab. For all CSC values, if albumin was \< 4 g/dL, the following formula was used to calculate CSC: CSC = Total serum calcium \[mg/dL\] + (0.8 x (4 - serum albumin \[g/dL\]))

Analysis population: Response Analysis Subset

Groups in this outcome

Denosumab

Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.

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

Analysis denominator · Participants

GroupSource count
Denosumab33

Reported measurements

By Day 2
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Denosumab9.1Not reported1.924.3Not reported
By Day 4
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Denosumab24.2Not reported11.142.3Not reported
By Day 8
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Denosumab48.5Not reported30.866.5Not reported
By Day 10
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Denosumab63.6Not reported45.179.6Not reported
By Day 15
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Denosumab63.6Not reported45.179.6Not reported
By Day 19
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Denosumab69.7Not reported51.384.4Not reported
By Day 23
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Denosumab69.7Not reported51.384.4Not reported
By Day 29
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Denosumab69.7Not reported51.384.4Not reported
By Day 36
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Denosumab69.7Not reported51.384.4Not reported
By Day 43
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Denosumab69.7Not reported51.384.4Not reported
By Day 50
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Denosumab69.7Not reported51.384.4Not reported
By Day 57
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Denosumab69.7Not reported51.384.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.9
        upper Limit
        24.3
        value
        9.1
    title
    By Day 2
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.1
        upper Limit
        42.3
        value
        24.2
    title
    By Day 4
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        30.8
        upper Limit
        66.5
        value
        48.5
    title
    By Day 8
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        45.1
        upper Limit
        79.6
        value
        63.6
    title
    By Day 10
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        45.1
        upper Limit
        79.6
        value
        63.6
    title
    By Day 15
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        51.3
        upper Limit
        84.4
        value
        69.7
    title
    By Day 19
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        51.3
        upper Limit
        84.4
        value
        69.7
    title
    By Day 23
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        51.3
        upper Limit
        84.4
        value
        69.7
    title
    By Day 29
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        51.3
        upper Limit
        84.4
        value
        69.7
    title
    By Day 36
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        51.3
        upper Limit
        84.4
        value
        69.7
    title
    By Day 43
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        51.3
        upper Limit
        84.4
        value
        69.7
    title
    By Day 50
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        51.3
        upper Limit
        84.4
        value
        69.7
    title
    By Day 57
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    units
    Participants
description
Response is defined as corrected serum calcium (CSC) ≤ 11.5 mg/dL, within 10 days after the first dose of denosumab. For all CSC values, if albumin was \< 4 g/dL, the following formula was used to calculate CSC: CSC = Total serum calcium \[mg/dL\] + (0.8 x (4 - serum albumin \[g/dL\]))
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
    id
    OG000
    title
    Denosumab
param Type
NUMBER
population Description
Response Analysis Subset
reporting Status
POSTED
time Frame
Days 2, 4, 8, 10, 15, 19, 23, 29, 36, 43, 50 and 57
title
Percentage of Participants With a Response by Visit
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice