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NCT00747123 · OUTCOME

Number of Participants With Skeletal-related Events (SRE)

A Safety, Tolerability and Efficacy Study of ACE-011 in Patients With Osteolytic Lesions of Multiple Myeloma · Source last updated 2024-10-03

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From first dose up to 2 weeks post first dose

What was measured

Skeletal-related events are defined as pathologic fracture, radiation therapy to bone, surgery to bone, or spinal cord compression, within 2 weeks of study enrollment. They are determined by skeletal surveys, including x-rays of the skull, entire spine, pelvis, ribs, humeri, and femora.

Analysis population: All randomized participants

Groups in this outcome

Placebo

Placebo was administered within 28 days of screening. Subsequent doses were administered every 28 days for a total of four doses.

0.1 mg/kg ACE 011

0.1 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169).

0.3 mg/kg ACE 011

0.3 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169)

0.5 mg/kg ACE 011

0.5 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169).

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

Analysis denominator · Participants

GroupSource count
Placebo6
0.1 mg/kg ACE 0118
0.3 mg/kg ACE 0118
0.5 mg/kg ACE 0118

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo0Not reportedNot reportedNot reportedNot reported
0.1 mg/kg ACE 0111Not reportedNot reportedNot reportedNot reported
0.3 mg/kg ACE 0112Not reportedNot reportedNot reportedNot reported
0.5 mg/kg ACE 0112Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      8
    4. group Id
      OG003
      value
      8
    units
    Participants
description
Skeletal-related events are defined as pathologic fracture, radiation therapy to bone, surgery to bone, or spinal cord compression, within 2 weeks of study enrollment. They are determined by skeletal surveys, including x-rays of the skull, entire spine, pelvis, ribs, humeri, and femora.
groups
  1. description
    Placebo was administered within 28 days of screening. Subsequent doses were administered every 28 days for a total of four doses.
    id
    OG000
    title
    Placebo
  2. description
    0.1 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169).
    id
    OG001
    title
    0.1 mg/kg ACE 011
  3. description
    0.3 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169)
    id
    OG002
    title
    0.3 mg/kg ACE 011
  4. description
    0.5 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169).
    id
    OG003
    title
    0.5 mg/kg ACE 011
param Type
COUNT_OF_PARTICIPANTS
population Description
All randomized participants
reporting Status
POSTED
time Frame
From first dose up to 2 weeks post first dose
title
Number of Participants With Skeletal-related Events (SRE)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice