NCT00396279 · OUTCOME

Number of Participants With Anti-Denosumab Antibodies

Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable Giant Cell Tumor of Bone · Source last updated 2022-11-08

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: From enrollment until the data cut-off date of April 7 2008; a maximum time of 18 months.

What was measured

Validated immunoassays were used to test for the presence of anti-denosumab antibodies throughout the study.

Analysis population: Participants who received at least 1 dose of denosumab and had at least 1 anti-denosumab antibody sample.

Groups in this outcome

Denosumab

Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.

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

Analysis denominator · Participants

Group	Source count
Denosumab	31

Reported measurements

Source class 1

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Denosumab	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0

denoms

counts
group Id
OG000
value
31
units
Participants

description

Validated immunoassays were used to test for the presence of anti-denosumab antibodies throughout the study.

groups

description
Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
id
OG000
title
Denosumab

param Type

NUMBER

population Description

Participants who received at least 1 dose of denosumab and had at least 1 anti-denosumab antibody sample.

reporting Status

POSTED

time Frame

From enrollment until the data cut-off date of April 7 2008; a maximum time of 18 months.

title

Number of Participants With Anti-Denosumab Antibodies

type

SECONDARY

unit Of Measure

participants

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

Preserved source evidence · Not medical advice