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NCT00445068 · OUTCOME

Safety and Tolerability

Efficacy and Safety of LBH589B in Adult Patients With Multiple Myeloma · Source last updated 2021-07-14

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From Start of the Study up to 57 Weeks approximately.

What was measured

Adverse Event (AE) are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.

Analysis population: The analysis was performed on Safety population consisted of all participants who had received at least one dose of study medication and had one valid post-baseline assessment.

Groups in this outcome

Panobinostat

Participants received panobinostat 20 mg orally OD, three times a week on days: 1, 3 and 5, then 8, 10 and 12, then 15, 17 and 19 of each cycle, as part of a 3-week (21 days) treatment cycle. Participants could continue treatment until disease progression or unacceptable toxicity.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Panobinostat38

Reported measurements

Participants with Adverse Events
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Panobinostat38Not reportedNot reportedNot reportedNot reported
Deaths
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Panobinostat7Not reportedNot reportedNot reportedNot reported
On treatment deaths
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Panobinostat3Not reportedNot reportedNot reportedNot reported
Serious Adverse Events
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Panobinostat17Not reportedNot reportedNot reportedNot reported
Study-drug-related Serious Adverse Events
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Panobinostat3Not reportedNot reportedNot reportedNot reported
Adverse Events Leading to discontinuation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Panobinostat8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        38
    title
    Participants with Adverse Events
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Deaths
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    On treatment deaths
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        17
    title
    Serious Adverse Events
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Study-drug-related Serious Adverse Events
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Adverse Events Leading to discontinuation
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    units
    Participants
description
Adverse Event (AE) are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
groups
  1. description
    Participants received panobinostat 20 mg orally OD, three times a week on days: 1, 3 and 5, then 8, 10 and 12, then 15, 17 and 19 of each cycle, as part of a 3-week (21 days) treatment cycle. Participants could continue treatment until disease progression or unacceptable toxicity.
    id
    OG000
    title
    Panobinostat
param Type
COUNT_OF_PARTICIPANTS
population Description
The analysis was performed on Safety population consisted of all participants who had received at least one dose of study medication and had one valid post-baseline assessment.
reporting Status
POSTED
time Frame
From Start of the Study up to 57 Weeks approximately.
title
Safety and Tolerability
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice