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NCT00896454 · OUTCOME

Percentage of Participants With a Response Within 10 Days of First Dose of Denosumab

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
10 days

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 including all participants who received at least 1 dose of denosumab and had a screening CSC (from local lab) \> 12.5 mg/dL (3.1 mmol/L).

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

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Denosumab63.6Not reported45.179.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        45.1
        upper Limit
        79.6
        value
        63.6
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 including all participants who received at least 1 dose of denosumab and had a screening CSC (from local lab) \> 12.5 mg/dL (3.1 mmol/L).
reporting Status
POSTED
time Frame
10 days
title
Percentage of Participants With a Response Within 10 Days of First Dose of Denosumab
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice