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NCT01023308 · OUTCOME

Time to Response Per Investigator Assessment (mEBMT Criteria) of Response Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.

Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma · Source last updated 2020-03-17

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

Measure
MEDIAN
Unit
time to response in months
Interval / dispersion
95% Confidence Interval
Time frame
45 months

Groups in this outcome

Panobinostat + Bortezomib

Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.

Placebo + Bortezomib

Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.

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

Analysis denominator · Participants

GroupSource count
Panobinostat + Bortezomib387
Placebo + Bortezomib381

Reported measurements

Source class 1
Values in time to response in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib1.51Not reported1.411.64Not reported
Placebo + Bortezomib2.00Not reported1.612.79Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.41
        upper Limit
        1.64
        value
        1.51
      2. group Id
        OG001
        lower Limit
        1.61
        upper Limit
        2.79
        value
        2.00
denoms
  1. counts
    1. group Id
      OG000
      value
      387
    2. group Id
      OG001
      value
      381
    units
    Participants
dispersion Type
95% Confidence Interval
groups
  1. description
    Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
    id
    OG000
    title
    Panobinostat + Bortezomib
  2. description
    Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
    id
    OG001
    title
    Placebo + Bortezomib
param Type
MEDIAN
reporting Status
POSTED
time Frame
45 months
title
Time to Response Per Investigator Assessment (mEBMT Criteria) of Response Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.
type
SECONDARY
unit Of Measure
time to response in months

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

Preserved source evidence · Not medical advice