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NCT00621244 · OUTCOME

Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every 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 1, Group X (20 mg)

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

Arm 1, Group x (30 mg)

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

Arm 1, Group X (40 mg)

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

Arm 1, Group X (60 mg)

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

Arm 1, Group X (80 mg)

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

Arm 1, Group Y (20 mg)

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

Arm 1, Group Y (30 mg)

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

Arm 1, Group Y (40mg)

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

Arm 1, 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 1, Group X (20 mg)8
Arm 1, Group x (30 mg)4
Arm 1, Group X (40 mg)7
Arm 1, Group X (60 mg)21
Arm 1, Group X (80 mg)8
Arm 1, Group Y (20 mg)1
Arm 1, Group Y (30 mg)4
Arm 1, Group Y (40mg)16
Arm 1, Group Y (60 mg)5

Reported measurements

Source class 1
Values in Percent Change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm 1, Group X (20 mg)56.697.26Not reportedNot reportedNot reported
Arm 1, Group x (30 mg)22.545Not reportedNot reportedNot reported
Arm 1, Group X (40 mg)63.287.21Not reportedNot reportedNot reported
Arm 1, Group X (60 mg)591.42438.34Not reportedNot reportedNot reported
Arm 1, Group X (80 mg)3170.04Not reportedNot reportedNot reported
Arm 1, Group Y (20 mg)66.7NANot reportedNot reportedthere was only 1 patient in the group, the standard deviation using the common Bessel correction cannot be derived.
Arm 1, Group Y (30 mg)150.0125.59Not reportedNot reportedNot reported
Arm 1, Group Y (40mg)196.3193.25Not reportedNot reportedNot reported
Arm 1, Group Y (60 mg)1998.54250.04Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        97.26
        value
        56.6
      2. group Id
        OG001
        spread
        45
        value
        22.5
      3. group Id
        OG002
        spread
        87.21
        value
        63.2
      4. group Id
        OG003
        spread
        2438.34
        value
        591.4
      5. group Id
        OG004
        spread
        70.04
        value
        31
      6. comment
        there was only 1 patient in the group, the standard deviation using the common Bessel correction cannot be derived.
        group Id
        OG005
        spread
        NA
        value
        66.7
      7. group Id
        OG006
        spread
        125.59
        value
        150.0
      8. group Id
        OG007
        spread
        193.25
        value
        196.3
      9. group Id
        OG008
        spread
        4250.04
        value
        1998.5
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      7
    4. group Id
      OG003
      value
      21
    5. group Id
      OG004
      value
      8
    6. group Id
      OG005
      value
      1
    7. group Id
      OG006
      value
      4
    8. group Id
      OG007
      value
      16
    9. group Id
      OG008
      value
      5
    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 week.
    id
    OG000
    title
    Arm 1, Group X (20 mg)
  2. description
    Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
    id
    OG001
    title
    Arm 1, Group x (30 mg)
  3. description
    Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
    id
    OG002
    title
    Arm 1, Group X (40 mg)
  4. description
    Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
    id
    OG003
    title
    Arm 1, Group X (60 mg)
  5. description
    Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
    id
    OG004
    title
    Arm 1, Group X (80 mg)
  6. description
    Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
    id
    OG005
    title
    Arm 1, Group Y (20 mg)
  7. description
    Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
    id
    OG006
    title
    Arm 1, Group Y (30 mg)
  8. description
    Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
    id
    OG007
    title
    Arm 1, Group Y (40mg)
  9. description
    Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
    id
    OG008
    title
    Arm 1, 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 in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week)
type
SECONDARY
unit Of Measure
Percent Change

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Preserved source evidence · Not medical advice