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NCT01083602 · OUTCOME

Overall Response Rate (PR+nCR+CR)

Efficacy of Panobinostat in Patients With Relapsed and Bortezomib-refractory Multiple Myeloma · Source last updated 2017-12-21

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
after eight cycyles of treatment (24 weeks)

What was measured

Overall response rate=(PR+nCR+CR) CR= \< 5% plasma cells in bone marrow. No confirmation on bone marrow plasma cell (additional assessment) is needed to document CR except patients with non-secretory myeloma where the bone marrow examination must be repeated after an interval of at least 6 weeks, Absence of M-protein in serum and urine by immunofixation,nCR same as CR without out Absence of M-protein in serum and urine by immunofixation,PR+ 50% reduction of serum M-protein and sofft tissue Plasmacytomas all for more than 6 weeks.

Analysis population: Full Analysis Set

Groups in this outcome

Panobinostat + Bortezomib & Dexamethasone

panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma

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 + Bortezomib & Dexamethasone55

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib & Dexamethasone34.5Not reported22.246.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22.2
        upper Limit
        46.7
        value
        34.5
denoms
  1. counts
    1. group Id
      OG000
      value
      55
    units
    Participants
description
Overall response rate=(PR+nCR+CR) CR= \< 5% plasma cells in bone marrow. No confirmation on bone marrow plasma cell (additional assessment) is needed to document CR except patients with non-secretory myeloma where the bone marrow examination must be repeated after an interval of at least 6 weeks, Absence of M-protein in serum and urine by immunofixation,nCR same as CR without out Absence of M-protein in serum and urine by immunofixation,PR+ 50% reduction of serum M-protein and sofft tissue Plasmacytomas all for more than 6 weeks.
dispersion Type
95% Confidence Interval
groups
  1. description
    panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
    id
    OG000
    title
    Panobinostat + Bortezomib & Dexamethasone
param Type
NUMBER
population Description
Full Analysis Set
reporting Status
POSTED
time Frame
after eight cycyles of treatment (24 weeks)
title
Overall Response Rate (PR+nCR+CR)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice