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NCT00621244 · OUTCOME

Highest Percent Change of Fetal Hemoglobin From Baseline in Arm 2 (MWF Every Other Week)

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
MEAN
Unit
Percent Change
Interval / dispersion
Standard Deviation
Time frame
Post dose to pre-dose (up to 3.5 years)

What was measured

All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (≤ 7 days post last dose (preferably ≥ 4 days \[96 hours\]))

Analysis population: Full Analysis Set (with available samples for analysis)

Groups in this outcome

Arm 2, Group X (30 mg)

Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week.

Arm 2, Group X (45 mg)

Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week.

Arm 2, Group X (60 mg)

Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week.

Arm 2, Group X (80 mg)

Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week.

Arm 2, Group Y (30 mg)

Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week.

Arm 2, Group Y (45 mg)

Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week.

Arm 2, Group Y (60 mg)

Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.

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 2, Group X (30 mg)3
Arm 2, Group X (45 mg)8
Arm 2, Group X (60 mg)7
Arm 2, Group X (80 mg)6
Arm 2, Group Y (30 mg)1
Arm 2, Group Y (45 mg)4
Arm 2, Group Y (60 mg)10

Reported measurements

Source class 1
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm 2, Group X (30 mg)96.2103.01Not reportedNot reportedNot reported
Arm 2, Group X (45 mg)67.7131.87Not reportedNot reportedNot reported
Arm 2, Group X (60 mg)59.3125.18Not reportedNot reportedNot reported
Arm 2, Group X (80 mg)34.247.88Not reportedNot reportedNot reported
Arm 2, Group Y (30 mg)0.0NANot reportedNot reportedAs the mean is 0, standard deviation is not applicable.
Arm 2, Group Y (45 mg)200.7210.73Not reportedNot reportedNot reported
Arm 2, Group Y (60 mg)376.0540.27Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        103.01
        value
        96.2
      2. group Id
        OG001
        spread
        131.87
        value
        67.7
      3. group Id
        OG002
        spread
        125.18
        value
        59.3
      4. group Id
        OG003
        spread
        47.88
        value
        34.2
      5. comment
        As the mean is 0, standard deviation is not applicable.
        group Id
        OG004
        spread
        NA
        value
        0.0
      6. group Id
        OG005
        spread
        210.73
        value
        200.7
      7. group Id
        OG006
        spread
        540.27
        value
        376.0
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      7
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      1
    6. group Id
      OG005
      value
      4
    7. group Id
      OG006
      value
      10
    units
    Participants
description
All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (≤ 7 days post last dose (preferably ≥ 4 days \[96 hours\]))
dispersion Type
Standard Deviation
groups
  1. description
    Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week.
    id
    OG000
    title
    Arm 2, Group X (30 mg)
  2. description
    Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week.
    id
    OG001
    title
    Arm 2, Group X (45 mg)
  3. description
    Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week.
    id
    OG002
    title
    Arm 2, Group X (60 mg)
  4. description
    Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week.
    id
    OG003
    title
    Arm 2, Group X (80 mg)
  5. description
    Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week.
    id
    OG004
    title
    Arm 2, Group Y (30 mg)
  6. description
    Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week.
    id
    OG005
    title
    Arm 2, Group Y (45 mg)
  7. description
    Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
    id
    OG006
    title
    Arm 2, Group Y (60 mg)
param Type
MEAN
population Description
Full Analysis Set (with available samples for analysis)
reporting Status
POSTED
time Frame
Post dose to pre-dose (up to 3.5 years)
title
Highest Percent Change of Fetal Hemoglobin From Baseline in Arm 2 (MWF Every Other Week)
type
SECONDARY
unit Of Measure
Percent Change

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

Preserved source evidence · Not medical advice