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NCT00920855 · OUTCOME

Summary of Participants With Adverse Events (AEs)

Study of Bendamustine Combined With Bortezomib for Patients With Relapsed/Refractory Multiple Myeloma · Source last updated 2012-10-04

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
up to 8.5 months. Deaths are reported up to 18 months

What was measured

Counts of participants who had AEs are summarized in a variety of categories. Severity and relatedness to study drug are in the opinion of the investigator according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0. Severity is rated on a 5-point scale: 1=mild, 2=moderate, 3=severe, 4=life threatening or disabling, and 5= death related to AE. Relatedness is assessed on a 5-point scale: not related, unlikely, possible, probable and definite. Definite, probable and possible answers are reported as 'related' to study medication. Deaths are reported up to 18 months. All the deaths occurred beyond the treatment-emergent timeframe since they occurred 6.5-16 months after the final dosing. All other parts of the summary represent the treatment-emergent timeframe (up to 8.5 months) which is the treatment period plus 30 days.

Analysis population: Safety population

Groups in this outcome

Bendamustine 50 mg/m^2 Cohort

Bortezomib 1.0 mg/m\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.

Bendamustine 70 mg/m^2 Cohort

Bortezomib 1.0 mg/m\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.

Bendamustine 90 mg/m^2 Cohort

Bortezomib 1.0 mg/m\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.

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

Analysis denominator · Participants

GroupSource count
Bendamustine 50 mg/m^2 Cohort5
Bendamustine 70 mg/m^2 Cohort4
Bendamustine 90 mg/m^2 Cohort31

Reported measurements

Any adverse event
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bendamustine 50 mg/m^2 Cohort5Not reportedNot reportedNot reportedNot reported
Bendamustine 70 mg/m^2 Cohort4Not reportedNot reportedNot reportedNot reported
Bendamustine 90 mg/m^2 Cohort31Not reportedNot reportedNot reportedNot reported
Any non-haematologic adverse event
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bendamustine 50 mg/m^2 Cohort5Not reportedNot reportedNot reportedNot reported
Bendamustine 70 mg/m^2 Cohort4Not reportedNot reportedNot reportedNot reported
Bendamustine 90 mg/m^2 Cohort31Not reportedNot reportedNot reportedNot reported
Severe adverse event (grade 3 or 4)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bendamustine 50 mg/m^2 Cohort3Not reportedNot reportedNot reportedNot reported
Bendamustine 70 mg/m^2 Cohort3Not reportedNot reportedNot reportedNot reported
Bendamustine 90 mg/m^2 Cohort22Not reportedNot reportedNot reportedNot reported
Treatment-related adverse events
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bendamustine 50 mg/m^2 Cohort4Not reportedNot reportedNot reportedNot reported
Bendamustine 70 mg/m^2 Cohort4Not reportedNot reportedNot reportedNot reported
Bendamustine 90 mg/m^2 Cohort31Not reportedNot reportedNot reportedNot reported
Deaths
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bendamustine 50 mg/m^2 Cohort1Not reportedNot reportedNot reportedNot reported
Bendamustine 70 mg/m^2 Cohort0Not reportedNot reportedNot reportedNot reported
Bendamustine 90 mg/m^2 Cohort5Not reportedNot reportedNot reportedNot reported
Serious adverse events
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bendamustine 50 mg/m^2 Cohort0Not reportedNot reportedNot reportedNot reported
Bendamustine 70 mg/m^2 Cohort1Not reportedNot reportedNot reportedNot reported
Bendamustine 90 mg/m^2 Cohort7Not reportedNot reportedNot reportedNot reported
Withdrawn from study due to AE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bendamustine 50 mg/m^2 Cohort2Not reportedNot reportedNot reportedNot reported
Bendamustine 70 mg/m^2 Cohort2Not reportedNot reportedNot reportedNot reported
Bendamustine 90 mg/m^2 Cohort5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        31
    title
    Any adverse event
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        31
    title
    Any non-haematologic adverse event
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        22
    title
    Severe adverse event (grade 3 or 4)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        31
    title
    Treatment-related adverse events
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        5
    title
    Deaths
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        7
    title
    Serious adverse events
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        5
    title
    Withdrawn from study due to AE
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      31
    units
    Participants
description
Counts of participants who had AEs are summarized in a variety of categories. Severity and relatedness to study drug are in the opinion of the investigator according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0. Severity is rated on a 5-point scale: 1=mild, 2=moderate, 3=severe, 4=life threatening or disabling, and 5= death related to AE. Relatedness is assessed on a 5-point scale: not related, unlikely, possible, probable and definite. Definite, probable and possible answers are reported as 'related' to study medication. Deaths are reported up to 18 months. All the deaths occurred beyond the treatment-emergent timeframe since they occurred 6.5-16 months after the final dosing. All other parts of the summary represent the treatment-emergent timeframe (up to 8.5 months) which is the treatment period plus 30 days.
groups
  1. description
    Bortezomib 1.0 mg/m\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
    id
    OG000
    title
    Bendamustine 50 mg/m^2 Cohort
  2. description
    Bortezomib 1.0 mg/m\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
    id
    OG001
    title
    Bendamustine 70 mg/m^2 Cohort
  3. description
    Bortezomib 1.0 mg/m\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
    id
    OG002
    title
    Bendamustine 90 mg/m^2 Cohort
param Type
NUMBER
population Description
Safety population
reporting Status
POSTED
time Frame
up to 8.5 months. Deaths are reported up to 18 months
title
Summary of Participants With Adverse Events (AEs)
type
SECONDARY
unit Of Measure
participants

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Preserved source evidence · Not medical advice