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NCT02654990 · OUTCOME

Overall Survival (OS)

Panobinostat/Bortezomib/Dexamethasone in Relapsed or Relapsed-and-refractory Multiple Myeloma · Source last updated 2024-07-12

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Up to 5.2 years

What was measured

OS is defined as the time from date of randomization to the date of death due to any cause.

Analysis population: Full analysis set (FAS): all participants to whom study treatment was assigned by randomization.

Groups in this outcome

Arm A - Panobinostat (20 mg, TIW)

Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.

Arm B - Panobinostat (20 mg, BIW)

Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.

Arm C - Panobinostat (10 mg, TIW)

Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.

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

Analysis denominator · Participants

GroupSource count
Arm A - Panobinostat (20 mg, TIW)82
Arm B - Panobinostat (20 mg, BIW)83
Arm C - Panobinostat (10 mg, TIW)83

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A - Panobinostat (20 mg, TIW)35Not reported27.8NANot evaluable due to insufficient number of events
Arm B - Panobinostat (20 mg, BIW)32Not reported30.7NANot evaluable due to insufficient number of events
Arm C - Panobinostat (10 mg, TIW)22Not reported18.6NANot evaluable due to insufficient number of events
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Not evaluable due to insufficient number of events
        group Id
        OG000
        lower Limit
        27.8
        upper Limit
        NA
        value
        35
      2. comment
        Not evaluable due to insufficient number of events
        group Id
        OG001
        lower Limit
        30.7
        upper Limit
        NA
        value
        32
      3. comment
        Not evaluable due to insufficient number of events
        group Id
        OG002
        lower Limit
        18.6
        upper Limit
        NA
        value
        22
denoms
  1. counts
    1. group Id
      OG000
      value
      82
    2. group Id
      OG001
      value
      83
    3. group Id
      OG002
      value
      83
    units
    Participants
description
OS is defined as the time from date of randomization to the date of death due to any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
    id
    OG000
    title
    Arm A - Panobinostat (20 mg, TIW)
  2. description
    Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
    id
    OG001
    title
    Arm B - Panobinostat (20 mg, BIW)
  3. description
    Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
    id
    OG002
    title
    Arm C - Panobinostat (10 mg, TIW)
param Type
MEDIAN
population Description
Full analysis set (FAS): all participants to whom study treatment was assigned by randomization.
reporting Status
POSTED
time Frame
Up to 5.2 years
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice