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NCT00621244 · OUTCOME

Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML)

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, progressive disease/failure, stable disease.

Analysis population: Full Analysis Set: defined according to the Intention to Treat (ITT) principle. This population set included all patients to whom study treatment had been assigned.

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 X59
Arm 2, Group X24

Reported measurements

Complete response (CR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Group X2Not 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 X1Not reportedNot reportedNot reportedNot reported
Arm 2, Group X1Not reportedNot reportedNot reportedNot reported
Stable disease (SD)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Group X25Not reportedNot reportedNot reportedNot reported
Arm 2, Group X10Not reportedNot reportedNot reportedNot reported
Progressive disease (PD)/failure
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Group X17Not reportedNot reportedNot reportedNot reported
Arm 2, Group X4Not reportedNot reportedNot reportedNot reported
Not evaluable
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Group X3Not reportedNot reportedNot reportedNot reported
Arm 2, Group X1Not reportedNot reportedNot reportedNot reported
Missing
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Group X11Not reportedNot reportedNot reportedNot reported
Arm 2, Group X8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
    title
    Complete response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    Partial remission (PR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        10
    title
    Stable disease (SD)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        4
    title
    Progressive disease (PD)/failure
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
    title
    Not evaluable
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        8
    title
    Missing
denoms
  1. counts
    1. group Id
      OG000
      value
      59
    2. group Id
      OG001
      value
      24
    units
    Participants
description
Response as per investigator assessment for patients include complete response, progressive disease/failure, stable disease.
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: defined according to the Intention to Treat (ITT) principle. This population set included all patients to whom study treatment had been assigned.
reporting Status
POSTED
time Frame
3.5 years
title
Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice