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NCT01484275 · OUTCOME

Overall Survival (OS)

A Study of Siltuximab (Anti- IL 6 Monoclonal Antibody) in Patients With High-risk Smoldering Multiple Myeloma · Source last updated 2020-01-27

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

Measure
MEDIAN
Unit
Days
Interval / dispersion
95% Confidence Interval
Time frame
Up to 4.7 Years

What was measured

OS is defined as the time between randomization and death due to any cause.

Analysis population: ITT population included participants who were randomly assigned to siltuximab or placebo treatment group based on an IVRS.

Groups in this outcome

Siltuximab

Participants received 15 milligram per kilogram (mg/kg) of siltuximab as a 1-hour intravenous (IV) infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).

Placebo

Participants received placebo as a 1-hour IV infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).

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

Analysis denominator · Participants

GroupSource count
Siltuximab43
Placebo42

Reported measurements

Source class 1
Values in Days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
SiltuximabNANot reportedNANAHere, NA signifies that median and confidence interval was not estimable due to less number of events.
PlaceboNANot reportedNANAHere, NA signifies that median and confidence interval was not estimable due to less number of events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Here, NA signifies that median and confidence interval was not estimable due to less number of events.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Here, NA signifies that median and confidence interval was not estimable due to less number of events.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      43
    2. group Id
      OG001
      value
      42
    units
    Participants
description
OS is defined as the time between randomization and death due to any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 15 milligram per kilogram (mg/kg) of siltuximab as a 1-hour intravenous (IV) infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
    id
    OG000
    title
    Siltuximab
  2. description
    Participants received placebo as a 1-hour IV infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
    id
    OG001
    title
    Placebo
param Type
MEDIAN
population Description
ITT population included participants who were randomly assigned to siltuximab or placebo treatment group based on an IVRS.
reporting Status
POSTED
time Frame
Up to 4.7 Years
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice