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NCT00621244 · OUTCOME

Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS)

A Study of Oral LBH589 in Adult Patients With Advanced Hematological Malignancies · Source last updated 2021-01-05

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

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
3.5 years

What was measured

Response as per investigator assessment for patients include complete response, stable disease, progressive disease/failure, partial remission.

Analysis population: Full Analysis Set

Groups in this outcome

Arm 1, Group X

panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.

Arm 2, Group X

panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.

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 1, Group X9
Arm 2, Group X2

Reported measurements

Complete response (CR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Group X0Not reportedNot reportedNot reportedNot reported
Arm 2, Group X0Not reportedNot reportedNot reportedNot reported
Stable disease (SD)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Group X4Not reportedNot reportedNot reportedNot reported
Arm 2, Group X1Not reportedNot reportedNot reportedNot reported
Progressive disease (PD)/failure
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Group X4Not reportedNot reportedNot reportedNot reported
Arm 2, Group X0Not reportedNot reportedNot reportedNot reported
Missing
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Group X1Not reportedNot reportedNot reportedNot reported
Arm 2, Group X0Not reportedNot reportedNot reportedNot reported
Partial remission (PR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Group X0Not reportedNot reportedNot reportedNot reported
Arm 2, Group X1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Complete response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        1
    title
    Stable disease (SD)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        0
    title
    Progressive disease (PD)/failure
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Missing
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Partial remission (PR)
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    2. group Id
      OG001
      value
      2
    units
    Participants
description
Response as per investigator assessment for patients include complete response, stable disease, progressive disease/failure, partial remission.
groups
  1. description
    panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
    id
    OG000
    title
    Arm 1, Group X
  2. description
    panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
    id
    OG001
    title
    Arm 2, Group X
param Type
NUMBER
population Description
Full Analysis Set
reporting Status
POSTED
time Frame
3.5 years
title
Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice